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Medical and Life Sciences
Business: Business Services: Quality Control and Tracking: Consulting
Science: Biology: Toxicology: Products and Services: Consultants
- European regulatory affairs company specialized in food safety assessment, food supplements, and European food legislation.
- Specialize in regulatory consulting and authorized representation in the European Union.
- Regulatory affairs consultants for ISO, GMP, and FDA compliance
- FDA compliance and regulatory consulting to help clients develop efficient and effective quality systems.
- GMP consultancy in Canada, assisting global pharmaceutical, biological, medical device, natural health products, and cosmetics companies with manufacturing or regulatory compliance issues.
- 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.
Aexelar Regulatory Experts
- Consortium of pharmaceutical regulatory affairs consulting services.
- Offers validation, ERP/CRM, testing, and enterprise efficiency services for medium and large scale organizations from Rockville, Maryland.
American Technical Consultants
- Consultant group specializing in providing services on FDA compliance issues to the food, drug and cosmetic industry.
Applied Regulatory Consulting Ltd
- Provides European regulatory consultancy to the pharmaceutical industry, including strategic regulatory consultancy, training, regulatory agency interactions, and regulatory submissions.
- Offering ISO 13485 and FDA QSR (21 CFR 820) Quality Manual and Operational Procedures and forms. Free software demo downloads available.
- Medical device consultant providing manufacturers with market approval, clinical evaluation, FDA Clearance as well as evaluation from public health authorities. Offices in London, UK and Buenos Aires. Argentina.
- 21 CFR Part 11 compliant digital and electronic signatures for any file format, document system, or web application.
- Provides compliance solutions for healthcare and financial sectors.
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.
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, pharmacogenomics, analyte specific reagent (ASR) regulatory compliance, and proteomics), medical device software (including bioinformatics), CPT coding reimbursement, and biotechnology-based products.
- Specialize in regulation of natural health products, health supplements, foods, pharmaceuticals, and cosmetics.
Brandt Research Consulting LLC
- Providing a wide range of consulting services in GCP, GLP and GMP compliance.
Cabridge Regulatory Services
- Specialists in the field of pharmaceutical regulatory affairs.
CATS Consultants GmbH
- EU regulatory affairs and preclinical/toxicological consulting.
Certified Compliance Solutions
- CCS is a software and process verification and validation provider for the medical device and pharmaceutical industries.
- 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.
- German consulting and engineering group with a focal on challenging capital investment projects in the Life Sciences industries.
- CIEX Incorporated is dedicated to Quality Software and provides services in Software Lifecycle Processes, Software Quality Assessments, Reliable Software Design.
CIMCON Software, Inc.
- Document, drawing and spreadsheet management solutions for US FDA compliant pharma manufacturing units.
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.
Clinical Device Group Inc.
- Offers full CRO services for medical devices manufacturers.
Coastal Consulting Group, Ltd.
- Medical device regulatory affairs, clinical studies, quality systems, and documentation services.
Coda Corp. USA
- Regulatory compliance and validation documentation consulting for FDA-regulated drug manufacturing and testing companies worldwide.
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.
- A commissioning, validation, cGMP, and regulatory compliance consulting services company.
- Dedicated to providing the Life Science industry with solutions to complex regulatory and business critical requirements.
Compliance Control Ltd.
- Provide software products and consultancy expertise to help companies achieve compliant and validated systems.
- 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.
Computer System Validation
- Consultant involved with the development, purchase, installation, operation and maintenance of computerized systems used in FDA compliant applications.
- CRO in drug development process in close collaboration with the preclinical and clinical departments of pharmaceutical and biotech companies.
Custom Business Development & Management Technology
- Assists companies in biotechnology, pharmaceutical and chemical markets with business development and market analysis.
Cyton Biosciences Ltd.
- European regulatory affairs consultancy providing specialist product development and registration services.
D & D Consulting LLC
- Provides validation, commissioning, and quality services to the pharmaceutical, biotechnology, and medical device industries.
Del Corno e Associati sas
- Services to the pharmaceutical industry, aimed at obtaining the appropriate authorizations in Italy and Europe.
- Delphi Consulting Group provides US FDA consulting services for medical devices.
Di Renzo Regulatory Affairs
- Provides regulatory services for human and veterinary medicines, mutual recognition, cosmetics, foods, medical devices, and translations. Rome, Italy.
- German consulting firm assists pharmaceutical and healthcare companies with regulatory matters relating to drugs, medical products, nutritional supplements, biocides, and cosmetics.
- Consultant for medical device importers, manufacturers, and physicians intending to introduce medical devices into U.S. commerce. Expert witness for neurological devices.
Draco Associates Ltd.
- Draco Associates offers regulatory affairs consulting and quality assurance consulting and services for pharmaceuticals, natural health products, and other regulated products.
DRW Research & Information Services, LLC
- Provides regulatory affairs research and information for the healthcare industry.
- A suite of three integrated NeeS/eCTD software products for the creation, validation, viewing, manipulation and archiving of NeeS/eCTD submissions.
- Resources, advice, and customer reviews to facilitate transition to eCTD software.
Ehrreich Consulting, Inc.
- Regulatory consultants expediting FDA approval by solving tough scientific, clinical, and regulatory issues which may arise pre- and post-submission.
- Regulatory affairs company with its HQ in Prague, Czech Republic assisting pharmaceutical and related industries with product registrations, GMP inspections, medical writing, clinical research/trials, bioequivalence studies. Regulatory services offered all EU languages.
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.
- Their employee development solutions provide for compliance management and learning management; their Gxp compliance Edition is "validation ready", ideal for GxP compliance training requirements in the pharmaceutical or medical device industries.
ERA Consulting Group
- Specialist services for biopharmaceutical companies in regulatory affairs, including the development/registration of biotechnology and biological medicinal products, with offices in Europe, United States and Australia.
Evolve Technologies, Inc
- Provide online privacy and security HIPAA training for business associates, employers, hospitals, clinics and health plans.
- Specialized on eCTD submissions.
EZ Risk Management
- ISO 14971 risk management software system for compliance with ISO 14971:2007.
- Professional network of regulatory affairs consultants and professionals.
- Live broadcasting of FDA meetings via video-conferencing, webcasting and audio-conferencing. Post-meeting webcasts, DVD, CDs, videotapes and transcripts available.
Flaig Pharma Consulting
- Consultant to the pharmaceutical industry in Germany and other European countries specialized in European drug registration procedures, CMC documents, CTAs, and product maintenance activities.
Ford and Associates
- Quality management experience in the medical device manufacturing with a focus on global regulatory compliance.
Gallandeer Ridge Pty Ltd
- Regulatory consultants to the pharmaceutical and medical device industry in Australia and New Zealand.
- Bio-Pharma professionals forum.
GCP Auditing Services
- An independent consultancy providing auditing services for all aspects of clinical trials and good clinical practice.
Global Regulatory Services
- Regulatory affairs services for the pharmaceutical, herbal, and biotech industries.
GLP Quality Consulting, LLC
- Consulting services for the pharmaceutical, biotech, and agricultural chemistry industries.
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.
GxP Medical Writing, LLC
- A medical communications company for scientific/medical editing and writing services.
- Offers Internet-based HIPAA privacy and confidentiality training software for payers, providers and academia as well as HIPAA-compliant medical billing software for providers.
HIPAA Exams, Inc.
- Online HIPAA training course and testing for healthcare professionals.
- Online self paced HIPAA training and compliance do-it-yourself kits.
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.
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 solutions.
IHL Consulting Group, Inc.
- FDA consultants based in Atlanta Georgia for the drug, biotechnology, biologics, and medical device industries.
IMI Consulting GmbH
- IMI Consulting GmbH is specialized in advising and implementing: strategy development, global marketing, business development, licensing, and mergers and acquisitions.
Independent Pharma Consultants
- Independent Pharma Consultants is a UK based regulatory affairs consultancy that offers a range of services.
- Turnkey solution for risk management needs that integrates sensitive surveillance with sophisticated signal detection, signal verification, and targeted prevention and intervention programs.
- GCP online training course provides a comprehensive guide to the basic principles, regulations, and guidelines of ICH good clinical practice.
Innovative Consultancy Services
- Indian pharmaceutical consultant company providing services in regulatory affairs, pharmaceutical dossiers, product/process development, and validation services.
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
- Assist in meeting regulatory obligations and minimizing liability risks.
- Regulatory consulting firm for international medical device companies interested in expanding their market penetration in Japan.
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.
Jouhou Koukai Services LLC
- Provider of pharmaceutical development, regulatory and business intelligence information on the Japanese pharma and medical device market.
Kamm & Associates
- Specializes in assisting businesses with compliance of GMP/QSR regulations.
- Kemic Bioresearch provides consulting, research and training in the pharmaceutical sciences (pharmacokinetics, pharmacology and toxicology).
Kennedy Writing Service (KWS)
- Medical writing and proofreading company.
Kobridge Consulting Ltd
- Quality and regulatory services to register medical devices in different markets. Supplier audits in Asia. Based in Korea.
- Offers consultancy services to prevent and resolve compliance problems and to develop strategies for the submission and approval of drugs, biologics, and devices.
Lewis CMC Consulting
- Provides pharmaceutical CMC regulatory consulting services, specializing in regulatory strategic, dossier preparation, and training services.
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.
Lorenz LIfe Sciences
- Regulatory affairs eCTD software and service for electronic submission management for companies with USA FDA, Canada, Europe, EMEA, Japan PMDA agencies.
Mandell Horwitz Consultants LLC
- Regulatory and scientific consulting for medical devices and other FDA-regulated products.
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 services offered in English, Portuguese, and Spanish.
Marion Weinreb and Associates, Inc.
- Assisting companies in the pharmaceutical, biotechnology, medical device, and diagnostic industries meet compliance and development needs.
- Validation and calibration services for the pharmaceutical, biotech, and related fields. Information on equipment and shipper studies.
The Matthews Consultancy
- European pharmaceutical/biotech consultancy specializing in project management, medical writing, and business development.
MDI Consultants. Inc.
- A quality assurance, regulatory, and clinical consulting firm providing services to the medical device, pharmaceutical and food industries.
Med Device Advisors
- Offer FDA compliant medical device standard operating procedures (SOP) for sale. Customization service is also available.
Medcon Taiwan, Inc.
- A Taiwan-based regulatory affairs consultant to the medical and life science industry
Medical Device Consultants
- Located in the Toronto, Ontario (Canada) region.
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.
- MEDIcept is a vertically integrated consulting firm specializing in contract engineering, quality assurance, and regulatory consulting.
- Consulting and service company based in Switzerland, engaged in regulatory affairs of pharmaceuticals, medical devices, and in vitro diagnostics.
- MundoMed is a consultancy based in Holland which specializes in CE-marking medical devices in Europe.
- NDA is a European regulatory affairs and patient safety consultancy.
NJK & Associates, Inc.
- NJK & Associates are a collaborative group of industry consultants serving the medical device and IVD industry.
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.
Octagon Research Solutions, Inc.
- Offers a suite of services that span the entire clinical research and development lifecycle.
- 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 medical device personnel.
Online GCP Training
- Online good clinical practice training.
Optimus Pharma Consulting
- Pharmaceutical consultants
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
Pennington Pharmaceutical Services LLC
- Regulatory compliance solutions targeted for small-to-medium sized pharmaceutical companies.
- Consulting group headquartered in Belgium. They manage biosafety and biotechnology compliance requirements.
PH PharmAnalysis GmbH
- Consultancy based in Germany that offers scientific and regulatory services for the pharmaceutical industry.
- Provides consulting services to pharmaceutical regulatory affairs professionals in the European Union.
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 cGMP inspections.
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.
- Consulting in regulatory strategy for medicinal products.
- For all European regulatory affairs issues - CTA/IMPD submissions, regulatory compliance issues, and CMC
- A fully integrated web-based eDMS and eCTD Submissions Solution Suite.
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.
- 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.
PRS Clinical Ltd
- Provider of clinical trial services
- 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.
- Specializing in CE marking, services for medical devices and also for manufacturers of personal protective equipment, in vitro diagnostics and medical test laboratories.
- Medical device, pharmaceutical, diagnostic, and other life science quality assurance and regulatory affairs consulting services.
- 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.
- 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.
- Service partner for international approval, registration, listing, and certification of medical devices in Europe, Asia, America, and Australia.
- An independent UK management consultancy working within the areas of product development specializing in medical devices and in-vitro diagnostics.
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
Quality Implementation Services Inc.
- Provides consulting services to pharmaceutical, medical device, and life sciences industries in quality assurance, quality control, and regulatory affairs compliance.
Quality Medical Regulations Services
- Provides quality assurance documentation support. Assists in site licensing, product registration, HACCP development and implementation. Ottawa, Canada.
- Validation Professionals, Inc. (VPI) offers a full range of validation, compliance and technical services for the pharmaceutical, biotechnology and medical device industries.
- Provide validations, cGxP compliance, systems engineering, and quality systems to pharmaceutical, medical device, and biotechnology industries.
- 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.
R. A. Q .A. Associates
- Provides FDA and ISO related consulting services to medical device and pharmaceutical companies. Specialize in helping firms with regulatory and cGMP problems, constructing and implementing entirely new quality and regulatory systems or improving existing systems.
- A collection of links to websites with information relating to regulatory affairs, regulatory intelligence, and the regulation of medicines.
- Provides international regulatory solutions to the pharmaceutical and biologics industries.
Regulatory Affairs Associates LLC
- RAA (regulatory affairs consultancy)
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).
- 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.
- Salamandra LLC provides strategic, technical, and regulatory consulting services to the pharmaceutical industry for drug, biologic, and device development.
- Offers a software package for the pharmaceutical industry that manages regulatory affairs and licence submissions.
- Consultant and advocate for the medical device industry on issues of regulatory and standards compliance, risk management (ISO 14971) and general device safety.
- Belgian company that provides consulting services in the fields of regulatory affairs, quality assurance, pricing and reimbursement, pharmacovigilance, and medical writing for medicinal products.
- 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.
- Firm specializing in providing SAS training and expertise in working with clinical trials.
- Sigma Biomedical supports biomedical research and medical device development by providing custom solutions.
Sindor Healthcare Consulting
- Based in Singapore, providing healthcare consulting including regulatory affairs, quality management systems, marketing, and business development.
SMB Validation and Compliance Group
- Works to get your equipment into production promptly while ensuring that all regulatory requirements are systematically fulfilled with a minimum of interference with operations.
Smith and Associates
- A consulting firm specializing in regulatory affairs for medical device manufacturing.
Strategic Compliance International, Inc.
- SCI, Inc. specializes in regulatory compliance consulting for biologics, medical devices and drug companies.
- Provides HIPAA training courses in multiple formats both onsite and online.
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).
- Provides the pharmaceutical, biologics and medical device industries with regulatory and compliance information. Includes services provided, company news and events.
- TDC Software is an engineering software suite covering risk management.
- Located in Barcelona, Spain - helps manufacturers to obtain CE mark for their medical devices.
Thermal Compliance Ltd
- Thermal mapping and autoclave validation
THINQ Compliance Ltd.
- The integration of services and software to provide competitive compliance, quality advocacy and thought leadership.
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.
- Regulatory affairs consultancy in Poland and EU (MRP, DCP, national, medical devices, food supplements, and scientific dossier consultation).
- A UK based company providing regulatory affairs consultancy and patient information leaflet user testing to the pharmaceutical industry.
- 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.
- European consultancy provides services to the FDA regulated pharmaceutical industry.
Universal Regulatory Inc.
- Specializing in regulatory strategy development, preparation, and review of regulatory submissions.
Validation in Partnership Ltd
- Specializing in the provision of validation and CGMP (Current Good Manufacturing Practice) compliance services.
Validation Online Net
- Generic downloadable documents that are cGMP compliant.
Validation Systems, Inc.
- They 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.
Validation Technologies, Inc.
- Worldwide validation, quality, compliance, and production services for the medical device, pharmaceutical, nutraceutical, and biotechnology industries.
- Danish regulatory affairs consultancy
VTS Consultants, Inc.
- Validation and regulatory consulting services for the pharmaceutical, biotechnology, and medical device industries.
- UK based regulatory affairs consultants offering a wide range of services to international companies in the pharmaceutical, medical device, nutritional and healthcare industry.
- A resource for issues surrounding the FDA's 21 CFR Part 11 Rule on electronic records and signatures.
- Medical device regulatory affairs
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.
- xFDA consulting provides services to small and mid-sized pharmaceutical and device companies including biotechnology in the areas of preclinical, clinical, CMC and regulatory.
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.
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