EpisKey Medical Consulting - Medical device consulting with extensive experience in medical devices. We offer solutions to the Medical Devices regulatory affairs to obtain CE mark. We help to obtain manufacturer licenses and design quality management systems. Tecno-med Ingenieros - Located in Barcelona, Spain - helps manufacturers to obtain CE mark for their medical devices. Ehrreich Consulting, Inc. - Regulatory consultants expediting FDA approval by solving tough scientific, clinical, and regulatory issues which may arise pre- and post-submission. Coda Corp. USA - Regulatory compliance and validation documentation consulting for FDA-regulated drug manufacturing and testing companies worldwide. 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. Kamm & Associates - Specializes in assisting businesses with compliance of GMP/QSR regulations. 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. 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. Entrinsik - 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. The Matthews Consultancy - European pharmaceutical/biotech consultancy specializing in project management, medical writing, and business development. Arazy Group - 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. American Technical Consultants - Consultant group specializing in providing services on FDA compliance issues to the food, drug and cosmetic industry. RegIntel Ltd. - Provides international regulatory solutions to the pharmaceutical and biologics industries. Lewis CMC Consulting - Provides pharmaceutical CMC regulatory consulting services, specializing in regulatory strategic, dossier preparation, and training services. 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. Regulatory Affairs Associates LLC - RAA (regulatory affairs consultancy) 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. Doctor Device - Consultant for medical device importers, manufacturers, and physicians intending to introduce medical devices into U.S. commerce. Expert witness for neurological devices. Brandt Research Consulting LLC - Providing a wide range of consulting services in GCP, GLP and GMP compliance. Validation Technologies, Inc. - Worldwide validation, quality, compliance, and production services for the medical device, pharmaceutical, nutraceutical, and biotechnology industries. 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 Tarius A/S - Provides the pharmaceutical, biologics and medical device industries with regulatory and compliance information. Includes services provided, company news and events. Medius AG - Consulting and service company based in Switzerland, engaged in regulatory affairs of pharmaceuticals, medical devices, and in vitro diagnostics. Compliance Associates - Dedicated to providing the Life Science industry with solutions to complex regulatory and business critical requirements. 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 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. 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. 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. 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. MDI Consultants. Inc. - A quality assurance, regulatory, and clinical consulting firm providing services to the medical device, pharmaceutical and food industries. reg-info.com - A collection of links to websites with information relating to regulatory affairs, regulatory intelligence, and the regulation of medicines. 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. FDALive.com - Live broadcasting of FDA meetings via video-conferencing, webcasting and audio-conferencing. Post-meeting webcasts, DVD, CDs, videotapes and transcripts available. Aitheras, LLC. - Offers validation, ERP/CRM, testing, and enterprise efficiency services for medium and large scale organizations from Rockville, Maryland. Jouhou Koukai Services LLC - Provider of pharmaceutical development, regulatory and business intelligence information on the Japanese pharma and medical device market. 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. Obelis Group - Offers CE marking, US agent services to non-European medical devices manufacturers under AIMD, MDD, and IVD, under EU directives from Brussels, Belgium. CIEX, Incorporated - CIEX Incorporated is dedicated to Quality Software and provides services in Software Lifecycle Processes, Software Quality Assessments, Reliable Software Design. Pharmalink Consulting - For all European regulatory affairs issues - CTA/IMPD submissions, regulatory compliance issues, and CMC PH PharmAnalysis GmbH - Consultancy based in Germany that offers scientific and regulatory services for the pharmaceutical industry. 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. Quality Medical Regulations Services - Provides quality assurance documentation support. Assists in site licensing, product registration, HACCP development and implementation. Ottawa, Canada. 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. Medcon Taiwan, Inc. - A Taiwan-based regulatory affairs consultant to the medical and life science industry Coastal Consulting Group, Ltd. - Medical device regulatory affairs, clinical studies, quality systems, and documentation services. Delphi Consulting Group - Provides US FDA consulting services for medical 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. FDC Services, LLC - A regulatory affairs and quality systems consulting company serving the medical device and pharmaceutical industries. Perseus Partners - Consulting group headquartered in Belgium. They manage biosafety and biotechnology compliance requirements. Masy BioServices - Helps life science companies analyze and improve the quality of their research laboratories and production environments, playing a focused role in the development and delivery of leading drugs and devices used to improve patients' lives. Innovative Consultancy Services - Indian pharmaceutical consultant company providing services in regulatory affairs, pharmaceutical dossiers, product/process development, and validation services. Smith and Associates - A consulting firm specializing in regulatory affairs for medical device manufacturing. Di Renzo Regulatory Affairs - Provides regulatory services for human and veterinary medicines, mutual recognition, cosmetics, foods, medical devices, and translations. Rome, Italy. Estrin Consulting Group, Inc. - ECG serves the medical device, pharmaceutical and cosmetic firms on FDA submissions, meetings and compliance related issues. Accurate Consultants - FDA compliance and regulatory consulting to help clients develop efficient and effective quality systems. Validation Professionals, Inc - Offers a full range of validation, compliance and technical services for the pharmaceutical, biotechnology and medical device industries. THINQ Compliance Ltd. - The integration of services and software to provide competitive compliance, quality advocacy and thought leadership. 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 Online Net - Generic downloadable documents that are cGMP compliant. Acerna Inc. - GMP consultancy in Canada, assisting global pharmaceutical, biological, medical device, natural health products, and cosmetics companies with manufacturing or regulatory compliance issues. Evolve Technologies, Inc - Provide online privacy and security HIPAA training for business associates, employers, hospitals, clinics and health plans. Sagaem For Life - 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. 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. Compliance Control Ltd. - Provide software products and consultancy expertise to help companies achieve compliant and validated systems. VTS Consultants, Inc. - Validation and regulatory consulting services for the pharmaceutical, biotechnology, and medical device industries. CATS Consultants GmbH - EU regulatory affairs and preclinical/toxicological consulting. Custom Business Development & Management Technology - Assists companies in biotechnology, pharmaceutical and chemical markets with business development and market analysis. Validation in Partnership Ltd - Specializing in the provision of validation and CGMP (Current Good Manufacturing Practice) compliance services. Cro.nu - CRO in drug development process in close collaboration with the preclinical and clinical departments of pharmaceutical and biotech companies. Supremus Group - Provides HIPAA training courses in multiple formats both onsite and online. 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. 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. Quality Vectors - Provide validations, cGxP compliance, systems engineering, and quality systems to pharmaceutical, medical device, and biotechnology industries. Qserve Group - 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. 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. Gamp Forum - Bio-Pharma professionals forum. Pharma-EU s.r.o. - Provides consulting services to pharmaceutical regulatory affairs professionals in the European Union. Kemic Bioresearch - Kemic Bioresearch provides consulting, research and training in the pharmaceutical sciences (pharmacokinetics, pharmacology and toxicology). 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. 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. 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. TRAC Services - A UK based company providing regulatory affairs consultancy and patient information leaflet user testing to the pharmaceutical industry. 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. Draco Associates Ltd. - Draco Associates offers regulatory affairs consulting and quality assurance consulting and services for pharmaceuticals, natural health products, and other regulated products. TDC Software - Engineering software suite covering risk management. 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. QSite - Consulting group focused on the medical device industry. Services include advice on international regulatory affairs, clinical affairs, biostatistics, and global quality assurance. Strategic Compliance International, Inc. - Specializes in regulatory compliance consulting for biologics, medical devices and drug companies. CIMCON Software, Inc. - Document, drawing and spreadsheet management solutions for US FDA compliant pharma manufacturing units. Cabridge Regulatory Services - Specialists in the field of pharmaceutical regulatory affairs. Mandell Horwitz Consultants LLC - Regulatory and scientific consulting for medical devices and other FDA-regulated products. Kobridge Consulting Ltd - Quality and regulatory services to register medical devices in different markets. Supplier audits in Asia. Based in Korea. Qarad - Specializing in CE marking, services for medical devices and also for manufacturers of personal protective equipment, in vitro diagnostics and medical test laboratories. Exalon - Specialized on eCTD submissions. 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. Sigma Biomedical - Supports biomedical research and medical device development by providing custom solutions. Computer System Validation - Consultant involved with the development, purchase, installation, operation and maintenance of computerized systems used in FDA compliant applications. 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. GLP Quality Consulting, LLC - Consulting services for the pharmaceutical, biotech, and agricultural chemistry industries. FarmavitaR+ - Professional network of regulatory affairs consultants and professionals. 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 Veirup Consult - Danish regulatory affairs consultancy Abrimed - Regulatory affairs consultants for ISO, GMP, and FDA compliance Infonetica - GCP online training course provides a comprehensive guide to the basic principles, regulations, and guidelines of ICH good clinical practice. PharmaReady - A fully integrated web-based eDMS and eCTD Submissions Solution Suite. Kennedy Writing Service (KWS) - Medical writing and proofreading company. 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. Shafi Consultancy - Firm specializing in providing SAS training and expertise in working with clinical trials. 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. IMI Consulting GmbH - IMI Consulting GmbH is specialized in advising and implementing: strategy development, global marketing, business development, licensing, and mergers and acquisitions. Cyton Biosciences Ltd. - European regulatory affairs consultancy providing specialist product development and registration services. 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. xFDA Inc. - Provides services to small and mid-sized pharmaceutical and device companies including biotechnology in the areas of preclinical, clinical, CMC and regulatory. MEDIcept - MEDIcept is a vertically integrated consulting firm specializing in contract engineering, quality assurance, and regulatory consulting. Abnovo Ltd - Specialize in regulatory consulting and authorized representation in the European Union. QualiMedd - An independent UK management consultancy working within the areas of product development specializing in medical devices and in-vitro diagnostics. HIPAATraining.com - Online self paced HIPAA training and compliance do-it-yourself kits. Global Regulatory Services - Regulatory affairs services for the pharmaceutical, herbal, and biotech industries. HIPAA Exams, Inc. - Online HIPAA training course and testing for healthcare professionals. Lorenz LIfe Sciences - Regulatory affairs eCTD software and service for electronic submission management for companies with USA FDA, Canada, Europe, EMEA, Japan PMDA agencies. NDA - NDA is a European regulatory affairs and patient safety consultancy. NJK & Associates, Inc. - A collaborative group of industry consultants serving the medical device and IVD industry. 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. Thermal Compliance Ltd - Thermal mapping and autoclave validation PRS Clinical Ltd - Provider of clinical trial services IHL Consulting Group, Inc. - FDA consultants based in Atlanta Georgia for the drug, biotechnology, biologics, and medical device industries. Chemgineering - German consulting and engineering group with a focal on challenging capital investment projects in the Life Sciences industries. D & D Consulting LLC - Provides validation, commissioning, and quality services to the pharmaceutical, biotechnology, and medical device industries. Universal Regulatory Inc. - Specializing in regulatory strategy development, preparation, and review of regulatory submissions. Quality Implementation Services Inc. - Provides consulting services to pharmaceutical, medical device, and life sciences industries in quality assurance, quality control, and regulatory affairs compliance. eCTD Office - A suite of three integrated NeeS/eCTD software products for the creation, validation, viewing, manipulation and archiving of NeeS/eCTD submissions. QMR, LLC - Medical device, pharmaceutical, diagnostic, and other life science quality assurance and regulatory affairs consulting services. Del Corno e Associati sas - Services to the pharmaceutical industry, aimed at obtaining the appropriate authorizations in Italy and Europe. Online GCP Training - Online good clinical practice training. TopPharm Consulting - Regulatory affairs consultancy in Poland and EU (MRP, DCP, national, medical devices, food supplements, and scientific dossier consultation). GCP Auditing Services - An independent consultancy providing auditing services for all aspects of clinical trials and good clinical practice. 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. Aclairo - 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. Quadras - Service partner for international approval, registration, listing, and certification of medical devices in Europe, Asia, America, and Australia. BNA consultants - Specialize in regulation of natural health products, health supplements, foods, pharmaceuticals, and cosmetics. Aexelar Regulatory Experts - Consortium of pharmaceutical regulatory affairs consulting services. PharmAssure - Australian pharmaceutical consulting services for validation and FDA and TGA GMP/GLP compliance. Diapharm - German consulting firm assists pharmaceutical and healthcare companies with regulatory matters relating to drugs, medical products, nutritional supplements, biocides, and cosmetics. EZ Risk Management - ISO 14971 risk management software system for compliance with ISO 14971:2007. Salamandra LLC - Provides strategic, technical, and regulatory consulting services to the pharmaceutical industry for drug, biologic, and device development. Seagull Comm.V - Belgian company that provides consulting services in the fields of regulatory affairs, quality assurance, pricing and reimbursement, pharmacovigilance, and medical writing for medicinal products. Compli - A commissioning, validation, cGMP, and regulatory compliance consulting services company. MundoMed - MundoMed is a consultancy based in Holland which specializes in CE-marking medical devices in Europe. Med Device Advisors - Offer FDA compliant medical device standard operating procedures (SOP) for sale. Customization service is also available. Ford and Associates - Quality management experience in the medical device manufacturing with a focus on global regulatory compliance. elc group - 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. Gallandeer Ridge Pty Ltd - Regulatory consultants to the pharmaceutical and medical device industry in Australia and New Zealand. Certified Compliance Solutions - CCS is a software and process verification and validation provider for the medical device and pharmaceutical industries. 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. Applied Regulatory Consulting Ltd - Provides European regulatory consultancy to the pharmaceutical industry, including strategic regulatory consultancy, training, regulatory agency interactions, and regulatory submissions. Japan MDC - Regulatory consulting firm for international medical device companies interested in expanding their market penetration in Japan. 1A-Food Consulting - European regulatory affairs company specialized in food safety assessment, food supplements, and European food legislation. eCTD Software - Resources, advice, and customer reviews to facilitate transition to eCTD software. Sindor Healthcare Consulting - Based in Singapore, providing healthcare consulting including regulatory affairs, quality management systems, marketing, and business development. Pennington Pharmaceutical Services LLC - Regulatory compliance solutions targeted for small-to-medium sized pharmaceutical companies. Prisym ID Life Sciences - Validated labeling systems and inventory management software systems designed specifically for FDA 21 CFR Part 11 regulated environments. Samarind Ltd - Offers a software package for the pharmaceutical industry that manages regulatory affairs and licence submissions. WMDE - Medical device regulatory affairs Azilon Corporation - Provides compliance solutions for healthcare and financial sectors. SeerPharma - Specializing in the delivery of technical compliance and validation, QA knowledge, and GMP training solutions to the pharmaceutical, medical device and biotechnology industries. 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. ADN - Compliance for electronic record management for FDA regulated companies. MWA Consulting, Inc. - Assisting companies in the pharmaceutical, biotechnology, medical device, and diagnostic industries meet compliance and development needs. Inflexxion, Inc. - Turnkey solution for risk management needs that integrates sensitive surveillance with sophisticated signal detection, signal verification, and targeted prevention and intervention programs. IMSXpress - Offering ISO 13485 and FDA QSR (21 CFR 820) Quality Manual and Operational Procedures and forms. Free software demo downloads available.