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Medical and Life Sciences Regulatory Affairs









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


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