Regulatory Affairs Medical and Life Sciences Consulting

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

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