Medical and Life Sciences Regulatory Affairs









  
  
    Top: Business: Business Services: Consulting: Medical and Life Sciences: Regulatory Affairs
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  • Estrin Consulting Group, Inc. - ECG serves the medical device, pharmaceutical and cosmetic firms on medical and life sciences FDA submissions, meetings and compliance related issues. Founder and President: medical and life sciences Norman F. Estrin, Ph.D. Regulatory Affairs Certified.
  • Draco Associates Ltd. - Draco Associates offers regulatory affairs consulting and quality medical and life sciences assurance consulting and services for pharmaceuticals, natural health medical and life sciences products, and other regulated products.
  • Arvin Shroff Associates LLC - Advisor to pharmaceutical, biotechnology, medical device, food, dietary supplements, and legal companies.
  • Perkins and Perkins - FDA consultants Perkins and Perkins, Inc. conduct mock FDA audits to insure Good Clinical Practice (GCP) compliance, quality assurance and FDA audit preparation.
  • Biologics Consulting Group - FDA regulatory experience and provide regulatory application support, consulting "mock" FDA regulatory affairs inspections, vendor and clinical trial site consulting audits, statistical services, clinical regulatory affairs trial design/review, and preparation consulting of responses to FDA compliance actions.
  • Veirup Consult - Danish regulatory affairs consultancy
  • Lewis CMC Consulting - Provides pharmaceutical CMC regulatory consulting services, specializing in regulatory affairs regulatory strategic, dossier preparation, and training services.
  • FDA Compliance Solutions - Consultants providing a full range of FDA compliance services, including medical and life sciences computer system validation, software validation, process validation, pharmaceutical validation and medical and life sciences consulting.
  • Obelis European Authorized Representative Center - Offers CE marking, US agent services to non-European medical devices manufacturers under AIMD, MDD, and IVD, under EU directives from Brussels, Belgium.
  • Lionpharm Regulatory Consulting GmbH - Lionpharm is an independent consultancy company providing all regulatory affairs kind medical and life sciences of regulatory affairs services covering the whole regulatory affairs life-cycle of medical and life sciences medicinal products in Europe.
  • CL Tech Inc. - Provide qualification, compliance, regulatory, training, and validation services to pharmaceutical, consulting medical device, and biotechnology industries. Specializing in facility, equipment consulting and Part 11 validations.
  • Mandell Horwitz Consultants LLC - Regulatory and scientific consulting for medical devices and medical and life medical and life sciences sciences other FDA-regulated products.
  • GMP Online Consultancy - European-based, Good Manufacturing Practice (GMP) online consultancy.
  • The Arazy Group - Medical Device RA and Quality System Consultants
  • KRM Associates - Regulatory due diligence advisory practice for the health consulting care industry regulatory affairs specialized in domestic & international regulatory consulting requirements for medical products regulatory affairs (e.g. medical devices, pharmaceutical, consulting tissue products, and in vitro diagnostics).
  • HIPAAdirect.com - A directory of HIPAA links.
  • TopPharm Consulting - Regulatory affairs consultancy in Poland and EU (MRP, regulatory affairs DCP, medical and life sciences national, medical devices, food supplements, and scientific regulatory affairs dossier consultation).
  • Accurate Consultants - FDA compliance and regulatory consulting to help clients regulatory affairs develop consulting efficient and effective quality systems.
  • Phoenix Regulatory Associates, Ltd - Regulatory affairs consultants based in the Washington DC regulatory affairs metro area with the industry and FDA expertise regulatory affairs to aid small to large pharmaceutical and medical regulatory affairs device companies.
  • xfda consulting - xFDA consulting provides services to small and mid-sized pharmaceutical and consulting device companies including biotechnology in the areas of preclinical, clinical, consulting CMC and regulatory.
  • GCP Auditing Services - An independent consultancy providing auditing services for all aspects of regulatory affairs clinical trials and good clinical practice.
  • Arham Consultants.com - Pharma regulatory affairs consultants based in New Delhi, consulting India for medical and life sciences the department of DCGI - Drugs consulting Controller General of India medical and life sciences - and NPPA - consulting National Pharmaceutical Pricing Authority.
  • Med Pharma Solutions, LLC - Provides on-site compliance consulting services including factory acceptance testing, commissioning, IQ/OQ/PQ\'s, validation and qualification services to the FDA regulated industries.
  • Medical Device Consultants, Inc. (MDCI) - Provides worldwide regulatory, clinical, and quality assurance consulting medical and life regulatory affairs sciences services to medical device and diagnostic product manufacturers medical and regulatory affairs life sciences to meet US, Canadian, and European requirements.
  • Kemic Bioresearch - Kemic Bioresearch provides consulting, research and training in the pharmaceutical regulatory affairs sciences (pharmacokinetics, pharmacology and toxicology).
  • Masy Systems - Validation and calibration services for the pharmaceutical, biotech, and related consulting fields. Information on equipment and shipper studies.
  • Atubra Inc. - Atubra provides a full range of consulting services consulting to FDA medical and life sciences regulated industries including drug, medical device, consulting cosmetic, and dietary supplement medical and life sciences companies.
  • Torrington Gower Consultants - Regulatory affairs consultants specializing in CMC/ Clinical National (UK and medical and life sciences IE) submissions (renewals and variations).
  • CMAC Consultancy - Provides services like documentation and change control, validation and qualification medical and life sciences execution, calibration and preventive maintenance, GXP training and implementation, project medical and life sciences administration and commissioning, as well as, IT services/operation managemen
  • Medprofile - Regulatory affairs consulting services for Thai FDA submissions.
  • Gamp Forum - Bio-Pharma professionals forum.
  • Kennedy Writing Service (KWS) - Medical writing and proofreading company.
  • Evolve Technologies, Inc - Provide online privacy and security HIPAA training for consulting business associates, employers, hospitals, clinics and health plans.
  • Quality First International Ltd. - QFI is a European based consultancy providing CE marking services, medical and life sciences EU Authorised Representative Programme, Microbiology Advisory Programme, QMS implementation, Conformity medical and life sciences Assessment support and compliance audits
  • NDA - NDA is a European regulatory affairs and patient regulatory affairs safety medical and life sciences consultancy.
  • Q-NET LLC - EU authorized representative service in accordance with the regulatory affairs EU medical and life sciences medical device directive and EU machinery directive. regulatory affairs Also act medical and life sciences as FDA US agent for foreign regulatory affairs establishments.
  • The Tamarack Group - Tamarack Group consultants (Charmaine Sutton, Carol DeSain) provide medical and life medical and life sciences sciences regulatory approvals and compliance services (GMP, QSR) for medical and medical and life sciences life sciences product development and manufacturers of medical products (US medical medical and life sciences and life sciences FDA, EU, Canada).
  • Pharmaceutical Development Group - Dr. Cheryl Blume and staff provide pharmaceutical and FDA regulatory regulatory affairs consulting services including, but not limited to, development of pharmacovigilance regulatory affairs assessment programs, pharmacokinetic protocols, non-clinical protocols and preparation for GCP/GLP regulatory affairs and
  • www.delcornosas.com/ - Services to the pharmaceutical industry, aimed at obtaining consulting the appropriate authorizations in Italy and Europe.
  • Lorenz LIfe Sciences - Regulatory affairs eCTD software and service for electronic submission management consulting for companies with USA FDA, Canada, Europe, EMEA, Japan PMDA consulting agencies.
  • Lachman Consultants - Offers consultancy services to prevent and resolve compliance consulting problems and regulatory affairs to develop strategies for the submission consulting and approval of drugs, regulatory affairs biologics, and devices.
  • Zodiac Pharmaceutical Services - Provides consulting services in the areas of patent, regulatory affairs regulatory medical and life sciences affairs, marketing research, and QA/GMP documentation for regulatory affairs small to medical and life sciences medium size pharmaceutical companies.
  • FDC Services, LLC - A regulatory affairs and quality systems consulting company serving the medical device and pharmaceutical industries.
  • Compliance Control Ltd. - Provide software products and consultancy expertise to help companies achieve consulting compliant and validated systems.
  • ADN - Compliance for electronic record management for FDA regulated medical and life regulatory affairs sciences companies.
  • UK Medical Device Consultancy - Provides medical device companies with business development services medical and life regulatory affairs sciences from regulatory affairs, quality systems to strategic reviews, medical and regulatory affairs life sciences marketing advice, strategic market research, product management from medical regulatory affairs and life sciences concept to market, business planning, distribution and
  • Tecno-med Ingenieros - Located in Barcelona, Spain - helps manufacturers to consulting obtain CE regulatory affairs mark for their medical devices.
  • PAT toolkit - Provides information on the FDA’s Process Analytical Technology regulatory affairs (PAT) regulatory affairs Initiative and outlines a software package to regulatory affairs help pharmaceutical regulatory affairs manufacturers implement this initiative.
  • RegulatoryPro.com - RegulatoryPro offers regulatory affairs consulting services to the medical and life consulting sciences biopharmaceutical, medical device and other FDA-regulated industries.
  • Paul Regulatory Services Limited - A regulatory affairs consultancy based in the UK.
  • Strategic Compliance International, Inc. - SCI, Inc. specializes in regulatory compliance consulting for medical and life medical and life sciences sciences biologics, medical devices and drug companies.
  • Online GCP Training - Online good clinical practice training.
  • Validation Technologies, Inc. - Worldwide validation, quality, compliance, and production services for consulting the medical medical and life sciences device, pharmaceutical, nutraceutical, and biotechnology industries.
  • American Technical Consultants - Consultant group specializing in providing services on FDA consulting compliance issues consulting to the food, drug and cosmetic consulting industry.
  • CanReg Inc. - Regulatory specialists provide strategy, submissions, and support for global clients.
  • D & D Consulting LLC - D & D Consulting LLC provides validation, commissioning, and quality services to the pharmaceutical, biotechnology, and medical device industries.
  • Infonetica - GCP online training course provides a comprehensive guide medical and life sciences to the basic principles, regulations, and guidelines of medical and life sciences ICH good clinical practice.
  • Barnhill & Associates, Inc. - A specialty based consulting firm specializing in a range of regulatory affairs scientific, laboratory, quality, and validation issues within the cGMP and regulatory affairs GLP arena.
  • eCTD Office - A suite of three integrated NeeS/eCTD software products regulatory affairs for the creation, validation, viewing, manipulation and archiving regulatory affairs of NeeS/eCTD submissions.
  • Ehrreich Consulting, Inc. - Regulatory consultants expediting FDA approval by solving tough regulatory affairs scientific, medical and life sciences clinical, and regulatory issues which may arise regulatory affairs pre- and medical and life sciences post-submission.
  • CATS Consultants GmbH - EU regulatory affairs and preclinical/toxicological consulting.
  • WellKang LLC - Regulatory affairs consultancy specializing in medical devices.
  • PinneyAssociates - Pinney Associates brings science and public health expertise to pharmaceutical, consumer healthcare, and biologics clients in risk management, over-the-counter switch, and marketing strategy.
  • Qware Riskmanager - A management system for the risk analysis for producers regulatory affairs of medical devices and in-vitro-diagnostics according to the world wide regulatory affairs valid standard DIN EN ISO 14971.
  • Cyton Biosciences Ltd. - European regulatory affairs consultancy providing specialist product development consulting and registration regulatory affairs services.
  • CIMCON Software, Inc. - Document, drawing and spreadsheet management solutions for US medical and life sciences FDA compliant pharma manufacturing units.
  • Independent Pharma Consultants - Independent Pharma Consultants is a UK based regulatory affairs consultancy that offers a range of services.
  • THINQ Compliance Ltd. - The integration of services and software to provide competitive compliance, quality advocacy and thought leadership.
  • FarmavitaR+ - Professional network of regulatory affairs consultants and professionals.
  • PharmaCon GmbH - Consulting in regulatory strategy for medicinal products.
  • QMR, LLC - Medical device, pharmaceutical, diagnostic, and other life science quality assurance and regulatory affairs consulting services.
  • Regulatory Bureau "Cratia" - Consulting and active assistance in registration (regulatory affairs) medical and life consulting sciences and clinical trials of medicinal products, API\\'s, supplements, medical and consulting life sciences and medical devices in CIS countries (Ukraine, Russian medical consulting and life sciences Federation, Kazakhstan, Moldova, Byelorussia).
  • The Matthews Consultancy - European pharmaceutical/biotech consultancy specializing in project management, medical regulatory affairs writing, medical and life sciences and business development.
  • Universal Regulatory Inc. - Specializing in regulatory strategy development, preparation, and review of regulatory regulatory affairs submissions.
  • Tumont Limited - Specializes in providing cGxP equipment and software validation consulting support to consulting pharmaceutical laboratories in UK. They can consulting provide plans, protocols, reports, consulting SOPs, inventories and training consulting on a fixed cost basis.
  • Global Quality Alliance, LLC - Team of GMP consultants and quality auditors that consulting provide consulting, regulatory affairs auditing, and training to the pharmaceutical, consulting biotechnology, API, dietary supplement, regulatory affairs pharmaceutical compounding, and medical consulting device industries.
  • RegIntel Ltd. - Provides international regulatory solutions to the pharmaceutical and biologics industries.
  • ARx Pharma, Inc. - Provide scientific and regulatory CMC consulting services to the global medical and life sciences pharmaceutical and biopharmaceutical industry through strategic design and implementation of medical and life sciences different aspects.
  • IMI Consulting GmbH - IMI Consulting GmbH is specialized in advising and implementing: strategy consulting development, global marketing, business development, licensing, and mergers and acquisitions.
  • Emergo Group, Inc. - Consultants to medical device companies for CE marking, authorized representative, FDA compliance and CCC mark for China. Offices in US, Europe and Asia.
  • Marion Weinreb and Associates, Inc. - Assisting companies in the pharmaceutical, biotechnology, medical device, consulting and diagnostic industries meet compliance and development consulting needs.
  • Acerna Inc. - GMP consultancy in Canada, assisting global pharmaceutical, biological, consulting medical device, medical and life sciences natural health products, and cosmetics companies consulting with manufacturing or regulatory medical and life sciences compliance issues.
  • ASG Inc. - Clinical Consulting: Specializing in regulatory affairs, sas programming, medical and life consulting sciences biotechnology careers, data management companies, staffing pharmaceutical, consulting, medical and consulting life sciences statistics, biotechnology, sas, and cro.
  • Jouhou Koukai Services LLC - Provider of pharmaceutical development, regulatory and business intelligence information on the Japanese pharma and medical device market.
  • FDALive.com - Live broadcasting of FDA meetings via video-conferencing, webcasting medical and life sciences and audio-conferencing. Post-meeting webcasts, DVD, CDs, videotapes medical and life sciences and transcripts available.
  • BrainWeaver, LLC - Online HIPAA training and compliance do-it-yourself kits.
  • ComplianceFDA, Inc. - FDA warning letter and CFR categorization and search medical and life consulting sciences database.
  • Coastal Consulting Group, Ltd. - Medical device regulatory affairs, clinical studies, quality systems, regulatory affairs and regulatory affairs documentation services.
  • HDM Corp. - Offers Internet-based HIPAA privacy and confidentiality training software consulting for payers, providers and academia as well as consulting HIPAA-compliant medical billing software for providers.
  • Wainwright Associates - UK based regulatory affairs consultants offering a wide consulting range of medical and life sciences services to international companies in the consulting pharmaceutical, medical device, nutritional medical and life sciences and healthcare industry.
  • Ceutical Labs - Provide infrastructure to small to medium sized businesses in pharmaceutical, regulatory affairs medical device, nutraceutical, pet, and cosmetic industries, including product development, regulatory affairs project management, validation, quality, regulatory affairs, IT, sales, and marketing
  • Octagon Research Solutions, Inc. - Offers a suite of services that span the medical and life sciences entire clinical research and development lifecycle.
  • Azilon Corporation - Provides compliance solutions for healthcare and financial sectors.
  • Medcon Taiwan, Inc. - A Taiwan-based regulatory affairs consultant to the medical and life consulting science industry
  • QSite - Qsite is a consulting group focused on the medical device regulatory affairs industry. Services include advice on international regulatory affairs, clinical affairs, regulatory affairs biostatistics, and global quality assurance.
  • Jim Colyn & Associates Quality Consultants, LLC - Consulting services targeting compliance and performance for human consulting tissue processors, tissue recovery organizations, organ procurement organizations, consulting eye banks, reproductive banks, and medical device manufacturers.
  • Oracle Consulting Group - Consultants for FDA and internationally regulated medical device firms, specializing in submissions, compliance, warning letter responses, inspection responses, quality system compliance, auditing and training
  • ProSource - ProSource has developed a portfolio of software solutions.
  • The Gnomon Group, LLC - Regulatory affairs consulting services based in Research Triangle Park NC covering the pharmaceutical and biotech industries, including regulatory strategy, FDA submissions, safety review, foreign company filings, and marketing review.
  • TDC Software - TDC Software is an engineering software suite covering risk management.
  • Validation and cGMP Compliance - Equipment and Software Validation. Part 11 of 21 CFR Compliance. medical and life sciences Regulations, cGMP, Validation knowledge base. FDA Warning letters.
  • SeerPharma - SeerPharma is a professional consultancy specializing in the delivery of consulting technical compliance and validation, QA knowledge, and GMP training solutions consulting to the pharmaceutical, medical device and biotechnology industries.
  • Quality Solutions - Validation Professionals, Inc. (VPI) offers a full range medical and life sciences of validation, compliance and technical services for the medical and life sciences pharmaceutical, biotechnology and medical device industries.
  • MDI Consultants. Inc. - A quality assurance, regulatory, and clinical consulting firm providing services regulatory affairs to the medical device, pharmaceutical and food industries.
  • Applied Regulatory Consulting Limited - Provides regulatory consultancy to the pharmaceutical industry, including regulatory affairs strategic regulatory consultancy, training, regulatory agency interactions, and regulatory affairs regulatory submissions.
  • Quality Medical Regulations Services - Provides quality assurance documentation support. Assists in site licensing, product registration, HACCP development and implementation. Ottawa, Canada.
  • Custom Business Development & Management Technology - Assists companies in biotechnology, pharmaceutical and chemical markets consulting with business medical and life sciences development and market analysis.
  • Samarind Regulatory Management Software - Samarind RMS is a software package for the pharmaceutical industry that manages regulatory affairs and licence submissions.
  • ERA Consulting Group - Specialist services for pharmaceutical companies in regulatory affairs, medical and life medical and life sciences sciences including the development/registration of biotechnology and biological medicinal medical and medical and life sciences life sciences products, with offices in Europe and the United medical medical and life sciences and life sciences States.
  • Validation Online Net - Generic downloadable documents that are cGMP compliant.
  • R. A. Q .A. Associates - R.A.Q.A. Associates provides FDA and ISO related consulting services to consulting medical device and pharmaceutical companies. We specialize in helping firms consulting with regulatory and cGMP problems, constructing and implementing entirely new consulting quality and regulatory system
  • Biotech Consultant LLC - Biotech Consultant LLC provides consulting services in the consulting scientific and regulatory affairs regulatory aspects of a wide range consulting of medical devices and regulatory affairs biologics with particular expertise consulting in the areas of in vitro regulatory affairs diagnostics (ELISA-based, consulting PCR-based, SNPs, microarrays, pharma
  • Carexa Inc. - Consultants providing strategy and services for drug development and regulatory consulting affairs.
  • ISOComp, Inc. - ISOtrain software distributors and consultants to bring training processes into FDA compliance and provide general consulting for pharmaceutical and biotechnology companies.
  • OMSBAR - OMSBAR provides consultancy services in regulatory affairs, product regulatory affairs registrations, export certification, training, project management and product regulatory affairs development, quality management, verification and validation, and maintains regulatory affairs a core staff of experienced medic
  • Clinical Device Group Inc. - Clinical Device Group offers full CRO services for regulatory affairs medical devices manufacturers.
  • Reg-info.com - A collection of links to websites with information consulting relating to regulatory affairs and the development of consulting medicines.
  • Quality Implementation Services Inc. - Provides consulting services to pharmaceutical, medical device, and regulatory affairs life consulting sciences industries in quality assurance, quality control, regulatory affairs and regulatory consulting affairs compliance.
  • Abrimed - Regulatory affairs consultants for ISO, GMP, and FDA compliance
  • Waters Corporation - A resource for issues surrounding the FDA\\'s 21 consulting CFR Part consulting 11 Rule on electronic records and consulting signatures.
  • NJK & Associates, Inc. - NJK & Associates are a collaborative group of medical and life sciences industry consultants serving the medical device and IVD medical and life sciences industry.
  • Regulatory Affairs, North America LLC - Regulatory affairs consultancy headquartered in North Carolina.
  • Sagaem - Sagaem is an Italian consultancy providing regulatory affairs and business development services to pharmaceutical companies wishing to approach the Italian market or enlarge their existing business in Italy.
  • Brandt Research Consulting LLC - Providing a wide range of consulting services in regulatory affairs GCP, GLP and GMP compliance.
  • IPMB GmbH - Institute for regulatory affairs and pharmaceutical services located consulting in Germany.
  • Regulatory Affairs Associates LLC - RAA (regulatory affairs consultancy)
  • Buphycon Consultancy - Provide scientific and regulatory affairs consultancy to investors, individual investigators, regulatory affairs and the biopharmaceutical industry operating in the field of vaccinology.
  • Reg123.com - Reg123.com is a portal for the new medicinal regulatory affairs product consulting development community with a focus on regulatory regulatory affairs affairs and consulting the pharmaceutical drug development process.
  • Karlton CMC Consulting - Specializing in pharmaceutical CMC regulatory affairs providing long medical and life sciences range strategic planning, technical writing, and in-house regulatory medical and life sciences affairs training.
  • Comply - Software packages for quality assurance processes such as management of medical and life sciences the documentation center, employee training records, environmental monitoring, deviations, CAPA, medical and life sciences stability studies, and trends analysis.
  • HIPAA Exams, Inc. - Online HIPAA training course and testing for healthcare regulatory affairs professionals.
  • Pharmacovigilance - Consultancy based in Italy that offers scientific services medical and life sciences and regulatory affairs for the pharmaceutical industry.
  • Chemgineering - German consulting and engineering group with a focal regulatory affairs on consulting challenging capital investment projects in the Life regulatory affairs Sciences industries.
  • ARX - 21 CFR Part 11 compliant digital and electronic medical and life regulatory affairs sciences signatures for any file format, document system, or medical and regulatory affairs life sciences web application.
  • Chestnut Solutions Inc. - Offers global regulatory strategies, document management, electronic submissions consulting and CTD filings to pharmaceutical and biotech companies consulting and contract research organizations in Canada, Europe and consulting the US.
  • Exalon - Specialized on eCTD submissions.
  • GLP Quality Consulting, LLC - Consulting services for the pharmaceutical, biotech, and agricultural regulatory affairs chemistry industries.
  • Smith and Associates - A consulting firm specializing in regulatory affairs for regulatory affairs medical regulatory affairs device manufacturing.
  • SDCS - Consultant and advocate for the medical device industry regulatory affairs on medical and life sciences issues of regulatory and standards compliance, risk regulatory affairs management (ISO medical and life sciences 14971) and general device safety.
  • Computer System Validation - Consultant involved with the development, purchase, installation, operation consulting and maintenance consulting of computerized systems used in FDA consulting compliant applications.
  • TRAC Services - A UK based company providing regulatory affairs consultancy medical and life consulting sciences and patient information leaflet user testing to the medical and consulting life sciences pharmaceutical industry.
  • PRS Clinical Ltd - Provider of clinical trial services
  • Validation Systems, Inc. - We provide contract and consulting services in the consulting following areas: consulting validation and technical services (IQ OQ consulting PQ protocols and validation consulting master plans VMP), quality consulting systems development, laboratory services, environmental monitoring, consulting and water consulting testing.
  • Pharma-EU s.r.o. - Provides consulting services to pharmaceutical regulatory affairs professionals in the consulting European Union.
  • Doctor Device - Consultant for medical device importers, manufacturers, and physicians medical and life sciences intending to introduce medical devices into U.S. commerce. medical and life sciences Expert witness for neurological devices.
  • International Regulatory Business Consultants, L.L.C. - Providing scientific and regulatory consultant services to the medical and life medical and life sciences sciences global pharmaceutical, nutritional supplement, medical device, and diagnostic medical and medical and life sciences life sciences product industries
  • Coda Corp. USA - Regulatory compliance and validation documentation consulting for FDA-regulated drug manufacturing medical and life sciences and testing companies worldwide.
  • MarcM Consulting Canada - Regulatory affairs consultants assisting pharmaceutical and related industries consulting with product medical and life sciences registrations, GMP inspections, ISO conformity, clinical consulting research/trials, bioequivalence studies, and medical and life sciences DMF preparations. Regulatory and consulting business development service
  • Pensa Technology Solutions Inc. - 21 cfr part 11 regulatory compliance of FDA medical and life consulting sciences pharmaceutical GMP validation for ERP life sciences computer medical and consulting life sciences information systems.
  • VTS Consultants, Inc. - Validation and regulatory consulting services for the pharmaceutical, biotechnology, and consulting medical device industries.
  • Regulatory Pharma - Regulatory Pharma provides regulatory affairs consultancy services (registration medical and life sciences and reimbursement of medicinal products (Rx, OTC, plant medical and life sciences origin), medical devices, food supplements, and cosmetics) in medical and life sciences Poland and Romania.
  • Shafi Consultancy - Firm specializing in providing SAS training and expertise in working with clinical trials.
  • QualiMedd - An independent UK management consultancy working within the medical and life sciences areas of product development specializing in medical devices medical and life sciences and in-vitro diagnostics.
  • Di Renzo Regulatory Affairs - Provides regulatory services for human and veterinary medicines, regulatory affairs mutual recognition, cosmetics, foods, medical devices, and translations. regulatory affairs Rome, Italy.
  • Regulatory Affairs Syndicator - This website syndicates material for regulatory affairs professionals. regulatory affairs Feeds regulatory affairs are obtained from a variety of global regulatory affairs resources about regulatory affairs the US Food and Drug Administration.
  • Qserve Group - Qserve® Group B.V provides CE Marking, quality management regulatory affairs system regulatory affairs implementation and auditing of ISO 13485, (pre)clinical regulatory affairs evaluation, product regulatory affairs market approval (e.g. CE/EU and FDA/USA) regulatory affairs and production registration regulatory affairs as well as other regulatory regulatory affairs services.
  • SMB Validation and Compliance Services Group - SMB Group is designed to get your equipment into production regulatory affairs promptly while ensuring that all regulatory requirements are systematically fulfilled regulatory affairs with a minimum of interference with operations.
  • PSF Medical - European business support and authorised representative for small consulting medical device consulting companies.
  • Alphapharma Consulting - Good Manufacturing Practice (GMP) consulting services to the medical and life consulting sciences pharmaceutical industry.
  • Aclairo - Aclairo is a drug development consultancy, based in regulatory affairs the regulatory affairs Washington DC area, focusing on preclinical toxicology, regulatory affairs pharmacology, regulatory regulatory affairs affairs issues, and U.S. Agent services regulatory affairs to non-U.S. biopharmaceutical regulatory affairs companies.
  • Al Weisenborn Medical Device Consulting - Regulatory affairs, quality assurance, custom software, and compliance consulting contracting and regulatory affairs consulting services.
  • Thermal Compliance Ltd - Thermal mapping and autoclave validation
  • Fulcrum Pharma - European consultancy with experience in all aspects of regulatory affairs and pharmacovigilance.
  • PH PharmAnalysis GmbH - Consultancy based in Germany that offers scientific and consulting regulatory services medical and life sciences for the pharmaceutical industry.
  • Global Regulatory Services - Regulatory affairs services for the pharmaceutical, herbal, and biotech industries.
  • Compliance Associates - Dedicated to providing the Life Science industry with consulting solutions to complex regulatory and business critical requirements.
  • Zeta Consulting - Informatics oriented organization involved in multiple validation and implementation projects medical and life sciences in the pharmaceutical and clinical trials industries.
  • Tarius A/S - Provides the pharmaceutical, biologics and medical device industries with regulatory and compliance information. Includes services provided, company news and events.
  • Pharmalink Consulting - For all European regulatory affairs issues - CTA/IMPD medical and life regulatory affairs sciences submissions, regulatory compliance issues, and CMC
  • AQA Co. - Offering ISO 13485 and FDA QSR (21 CFR 820) Quality consulting Manual and Operational Procedures and forms. Free software demo consulting downloads available.
  • Validation in Partnership Ltd - Specializing in the provision of validation and CGMP medical and life consulting sciences (Current Good Manufacturing Practice) compliance services.
  • CLINSTEP LLC - Multilingual regulatory affairs consultancy for medical devices, pharmaceuticals regulatory affairs and diagnostic devices.
  • Innovative Automation - Part 11 compliance software solutions designed for MS-Excel, consulting MS-Word, electronic laboratory notebook, and file replication.
  • Perseus Partners - Consulting group headquartered in Belgium. They manage biosafety medical and life regulatory affairs sciences and biotechnology compliance requirements.
  • Medius AG - Consulting and service company based in Switzerland, engaged consulting in regulatory affairs of pharmaceuticals, medical devices, and consulting in vitro diagnostics.
  • MEDIcept - MEDIcept is a vertically integrated consulting firm specializing regulatory affairs in regulatory affairs contract engineering, quality assurance, and regulatory consulting.
  • PRISYM ID Compliant Barcode & Labeling - 21 CFR Part 11 validated barcode and labeling consulting solutions for pharmaceutical and medical device manufacturers.
  • IHL Consulting Group, Inc. - FDA consultants based in Atlanta Georgia for the regulatory affairs drug, biotechnology, biologics, and medical device industries.
  • Sigma Biomedical - Sigma Biomedical supports biomedical research and medical device development by providing custom solutions.
  • Quality Vectors - Provide validations, cGxP compliance, systems engineering, and quality consulting systems to consulting pharmaceutical, medical device, and biotechnology industries.
  • CompliaPharm, LLC - Quality and regulatory compliance consulting services for the consulting life sciences industry.
  • Kamm & Associates - Specializes in assisting businesses with compliance of GMP/QSR consulting regulations.
  • 21 CFR Consulting - Privately held virtual company in Encinitas, California, offering quality and medical and life sciences risk assessments, remediation, IT system validation and training for FDA medical and life sciences regulated industries.
  • The Horizon Phoenix Group LLC - Quality/regulatory consultants for medical device, pharmaceutical and biotechnology industries. Services include: CE Marking, Authorized European Representative, USFDA, 510ks, PMAs, US Agent and Canadian Licenses.
  • QRC Associates - QRC Associates provides management with cGMP and QSR advice.
  • CIEX, Incorporated - CIEX Incorporated is dedicated to Quality Software and consulting provides services consulting in Software Lifecycle Processes, Software Quality consulting Assessments, Reliable Software Design.
  • Regulatory Affairs Consulting - Regulatory affairs consulting services to the pharmaceutical and related industries.
  • Wolter Kluwers MediRegs - Compliance and risk management software solutions for your medical and life sciences business. Specializing in healthcare billing compliance, ERM (enterprise medical and life sciences risk management), food, drug and medical device compliance, medical and life sciences and grant management compliance.
  • Pharmaceutical registration in EU and CEE - Offers drug and medical devices registration and maintenance in EU.
  • Innovative Consultancy Services - Indian pharmaceutical consultant company providing services in regulatory regulatory affairs affairs, consulting pharmaceutical dossiers, product/process development, and validation services.
  • Mediqol - Offers a range of medical device consultancy services consulting throughout Europe regulatory affairs (including CE marking, regulatory and clinical consulting trials management).
  • DRW Research & Information Services, LLC - Provides regulatory affairs research and information for the consulting healthcare industry.
  • Thomas E. Colonna Ph.D./J.D. & Associates - Provides consulting services in the scientific and regulatory regulatory affairs aspects of a wide range of medical devices regulatory affairs with particular expertise in the areas of in regulatory affairs vitro diagnostics and biotechnology-based products.
  • Cabridge Regulatory Services - Specialists in the field of pharmaceutical regulatory affairs.
  • Creative Consultants - India-based agency engaged in preparation of registration dossiers medical and life sciences for export of drug formulations. We also prepare medical and life sciences clinical trial reports, training manuals, drug master files, medical and life sciences SOPs, and validation reports.
  • Delphi Consulting - Delphi Consulting Group provides US FDA consulting services consulting for medical consulting devices.
  • Global Regulatory - Pharmaceutical, medical device, biotechnology, food, and nutraceutical consulting regulatory affairs for consulting the international markets.
  • Kobridge Consulting Ltd - Korean consultants to medical device companies for CE medical and life consulting sciences marking, Canadian approvals, and FDA compliance.
  • Drumbeat Dimensions Inc. - Professional compliance management company dedicated to developing products consulting and tools for assessing, enhancing, and maintaining regulatory consulting compliance.
  • Perfect Consultants - Association of consultants engaged in providing regulatory support regulatory affairs to Pharmaceutical and Active Pharma Ingredients (API) industries.
  • Joe Schwoebel, BSEE, MBA - Offers consulting services related to product planning, clinical study, regulatory regulatory affairs affairs and reimbursement strategy. Includes resume, certifications and press releases, regulatory affairs and FDA approvals.
  • BesTech - Consulting services guides medical companies through the FDA medical and life medical and life sciences sciences and CE compliance processes to ensure their business medical and medical and life sciences life sciences success. Provide solutions for regulatory compliance, product safety, medical medical and life sciences and life sciences litigation support and design and development of medical medical and life sciences medical and life sciences devices.
  • eCTDusergroup - Italian professional community on e-ctd and e-submission topics.
  • Shay Ginsbourg - Israeli consultant experienced in various regulatory certifications, as well as, verification and validation of software and medical devices.
  • Aitheras, LLC. - Offers validation, ERP/CRM, testing, and enterprise efficiency services consulting for medium and large scale organizations from Rockville, consulting Maryland.
  • Coding Compliance Solutions - Consulting firms specializing in supporting hospitals, physicians and consulting attorneys address medical and life sciences complex coding issues. Major emphasis consulting on working with counsel medical and life sciences in support of fraud consulting and abuse allegations from third-party payers.
  • Quality Systems Laboratories - Provides compliance process management and eLearning products and consulting services.
  • Regulatory Services Co., Inc. - Regulatory affairs and quality assurance consulting for entrepreneurial medical and life consulting sciences medical device companies.
  • Cro.nu - CRO in drug development process in close collaboration regulatory affairs with the preclinical and clinical departments of pharmaceutical regulatory affairs and biotech companies.
  • Entrinsik - Their employee development solutions provide for compliance management medical and life regulatory affairs sciences and learning management; our Gxp compliance Edition is medical and regulatory affairs life sciences "validation ready", ideal for GxP compliance training requirements medical regulatory affairs and life sciences in the pharmaceutical or medical device industries.
  • Supremus Group - Provides HIPAA training courses in multiple formats both consulting onsite and online.
  • Pharmaceutical Regulatory Services, Inc. - Provide clinical and regulatory support of all phases medical and life medical and life sciences sciences of global drug development with operations in over medical and medical and life sciences life sciences 80 countries on all continents.
  • Qarad - Specializing in CE marking, services for medical devices regulatory affairs and consulting also for manufacturers of personal protective equipment, regulatory affairs in vitro consulting diagnostics and medical test laboratories.
  • Seraphim Life Sciences Consulting LLC - Seraphim provides integrated consulting and due diligence on regulatory and regulatory affairs operations issues for life sciences companies and investors.
  • PharmaReady - PharmaReady™ is a fully integrated web-based eDMS and consulting eCTD Submissions Solution Suite.
  • GCP Solutions - GCP Solutions provides good clinical practice consulting services.
  • IDEC Validation Ltd - Provider of Quality and Compliance services to the medical and life consulting sciences Pharmaceutical / Biotechnology sector. Primarily assist organisations in medical and consulting life sciences the CSV field satisfy Regulatory and Compliance requirements. medical consulting and life sciences IVL has field knowledge in the implementation consulting medical and life sciences of compliance solution
  • Inflexxion, Inc. - Turnkey solution for risk management needs that integrates sensitive surveillance with sophisticated signal detection, signal verification, and targeted prevention and intervention programs.
  • Spherelink FDA Consulting - Spherelink provides FDA consulting and international trade consulting consulting between Asia regulatory affairs and the United States.
  • Leonard T. Flynn - An independent regulatory and scientific consultant who provides assistance to pharmaceutical, health product and chemical manufacturers for them to meet the requirements of government agencies.
  • Harpaz Consulting Services - Providing GMP compliance consultation, regulatory and technical expertise to manufacturers regulatory affairs of drug products, active pharmaceutical ingredients, and medical devices worldwide.
  • Karandikar Laboratories Pvt. Ltd. - Test and calibration laboratory located in India.
  • Abnovo Ltd - Specialize in regulatory consulting and authorized representation in regulatory affairs the regulatory affairs European Union.
  • SimPILy Read - Offers patient information leaflet readability tests, compliance reviews and advice medical and life sciences on leaflet improvement for international pharmaceutical and traditional herbal medicines medical and life sciences industries.


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