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Medical and Life Sciences Regulatory Affairs









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


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