Categories related to Business: Business Services: Consulting: Medical and Life Sciences: Regulatory Affairs: Business: Business Services: Quality Control and Tracking: Consulting (229) Science: Biology: Toxicology: Products and Services: Consultants (10) Websites on Regulatory Affairs: A. Arham Associates 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. Abnovo Ltd Specialize in regulatory consulting and authorized representation in the European Union. Abrimed Regulatory affairs consultants for ISO, GMP, and FDA compliance Accurate FDA Consultants FDA compliance and regulatory consulting to help clients develop efficient and effective quality systems. Acerna Inc. GMP consultancy in Canada, assisting global pharmaceutical, biological, medical device, natural health products, and cosmetics companies with manufacturing or regulatory compliance issues. ADN Compliance for electronic record management for FDA regulated companies. Aitheras, LLC. Offers validation, ERP/CRM, testing, and enterprise efficiency services for medium and large scale organizations from Rockville, Maryland. Allegheny Associates - Regulatory and Clinical Affairs Consulting Joe Schwoebel is General Manager of Allegheny Associates. The consultancy provides services related to medical product planning, clinical study, regulatory affairs and reimbursement strategy. Alphapharma Consulting Good Manufacturing Practice (GMP) consulting services to the pharmaceutical industry. Applied Regulatory Consulting Ltd - experience applied for pharmaceuticals Applied Regulatory Consulting Limited provides regulatory consultancy to the pharmaceutical industry, including strategic regulatory consultancy, training, regulatory agency interactions, and regulatory submissions. AQA Offering ISO 13485 and FDA QSR (21 CFR 820) Quality Manual and Operational Procedures and forms. Free software demo downloads available. The Arazy Group Medical Device RA and Quality System Consultants Arvin Shroff Associates LLC Advisor to pharmaceutical, biotechnology, medical device, food, dietary supplements, and legal companies. ARX - Digital Signature Solutions 21 CFR Part 11 compliant digital and electronic signatures for any file format, document system, or web application. ARx Pharmaceutical Regulatory Consultancy LLC Provide scientific and regulatory CMC consulting services to the global pharmaceutical and biopharmaceutical industry through strategic design and implementation of different aspects. ASG Inc. Clinical Consulting: Specializing in regulatory affairs, sas programming, biotechnology careers, data management companies, staffing pharmaceutical, consulting, statistics, biotechnology, sas, and cro. ATC Corp. - American Technical Consultants Consultant Group specializing in providing services on FDA Compliance Issues to the Food, Drug and Cosmetic industry. Atubra Inc. Atubra provides a full range of consulting services to FDA regulated industries including drug, medical device, cosmetic, and dietary supplement companies. Barnhill & Associates, Inc. - Pharmaceutical Consultants A specialty based consulting firm specializing in a range of scientific, laboratory, quality, and validation issues within the cGMP and GLP arena. BesTech regulatory consulting 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. 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 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. Brandt Research Consulting LLC Providing a wide range of consulting services in GCP, GLP and GMP compliance. Buphycon Consultancy Provide scientific and regulatory affairs consultancy to investors, individual investigators, and the biopharmaceutical industry operating in the field of vaccinology. BuzzeoPDMA, Inc. PDMA Compliance Auditing Service, Reconciliation Services, Field Inventory and System Auditing Services and Validation, State Requirements and Licensing, DEA Regulatory and Operational Solutions, Training, Security Vulnerability Assessment (SVA). Cabridge Regulatory Services Specialists in the field of pharmaceutical regulatory affairs. Carexa Inc. Regulatory Consultants Carexa's experienced consultants provide strategy and services for drug development and regulatory affairs. CATS Consultants EU regulatory affairs and preclinical/toxicological consulting. 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. 21 CFR Consulting Privately held virtual company in Encinitas, California, offering quality and risk assesments, remediation, IT system validation and training for FDA regulated industries. 21 CFR Part 11 Compliance Resource A resource for issues surrounding the FDA's 21 CFR Part 11 Rule on electronic records and signatures. 21 CFR Part 11 Compliance Software Solutions Part 11 compliance software solutions designed for MS-Excel, MS-Word, electronic laboratory notebbook, and file replication. 21 CFR Part 11 Compliant Solutions Document, drawing and spreadsheet management solutions for US FDA compliant pharma manufacturing units. 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. CIEX, Incorporated CIEX Incorporated is dedicated to Quality Software and provides services in Software Lifecycle Processes, Software Quality Assessments, Reliable Software Design. 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. Clinical Device Group offers full CRO services for medical devices manufacturers. 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 management. 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. Compliance Associates 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. ComplianceFDA, Inc. FDA warning letter and CFR categorization and search database. CompliaPharm, LLC Quality and regulatory compliance consulting services for the life sciences 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. Computer System Validation Consultant involved with the development, purchase, installation, operation and maintenance of computerized systems used in FDA compliant applications. Consultifarma Consultoria especializada no registro de produtos e empresas sujeitas a vigilancia sanitaria, assim como em atividades que abrangem: pesquisa clinica, controle de qualidade e estabilidade, treinamento, marketing farmaceutico etc. Corporate Consulting Enterprises, LLC Provide mock audits, quality systems assessments, and liaison services with the FDA. Creative Consultants India 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. Cro.nu 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. Delphi Consulting Delphi Consulting Group provides US FDA consulting services for medical devices. Di Renzo Regulatory Affairs Di Renzo Regulatory Affairs is a pharmaceutical consultant aiding companies that need to register products (from medicines/dietary supplements and medical devices to cosmetics) at the AIFA and the Italian Ministry of Health. Doctor Device Consultant 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. Drumbeat Dimensions Inc. Professional compliance management company dedicated to developing products and tools for assessing, enhancing, and maintaining regulatory compliance. DRW Research & Information Services, LLC Provides regulatory affairs research and information for the healthcare industry. eHIPAA Training Provide online privacy and security HIPAA training for business associates, employers, hospitals, clinics and health plans. Ehrreich Consulting, Inc. Regulatory consultants expediting FDA approval by solving tough scientific, clinical, and regulatory issues which may arise pre- and post-submission. Emergo Group Consultants to medical device companies for CE marking, authorized representative, FDA compliance and CCC mark for China. Offices in US, Europe and Asia. Emergo Group Consultants to medical device companies for CE marking, authorized representative, FDA compliance and CCC mark for China. Offices in US, Europe and Asia. Enterprise Risk and Compliance Management Provides compliance solutions for Healthcare and Financial Sector. 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. 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. 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. European Authorized Representative Offers CE marking, US agent services to non-European medical devices manufacturers under AIMD, MDD, and IVD, under EU directives from Brussels, Belgium. European consulting for the healthcare industry Specializing in CE marking, services for medical devices and also for manufacturers of personal protective equipment, in vitro diagnostics and medical test laboratories. European Pharmaceutical Consultants European Pharmaceutical Consultants (EPC), s.r.o. provides consulting services to pharmaceutical regulatory affairs professionals in the European Union. Exalon Specialized on eCTD submissions. FarmavitaR+ : Regulatory Affairs Network FarmavitaR+ is a professional network of regulatory affairs consultants and professionals. FDA Advisors with scientific and technical expertise 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. FDA Compliance Solutions FDA Compliance Solutions' consultants provide a full range of FDA compliance services, including computer system validation, software validation, process validation, pharmaceutical validation and consulting. FDALive.com Live broadcasting of FDA meetings via video-conferencing, webcasting and audio-conferencing. Post-meeting webcasts, DVD, CD's, videotapes and transcripts available. FDC Services A regulatory affairs and quality systems consulting company serving the medical device and pharmaceutical industries. Gamp Forum Bio-Pharma professionals forum. GCP Auditing Services An independent consultancy providing auditing services for all aspects of clinical trials and good clinical practice. GCP cursus Cursussen Good Clinical Practice GCP Solutions GCP Solutions provides good clinical practice consulting services. GCP Training Online GCP online training course provides a comprehensive guide to the basic principles, regulations, and guidelines of ICH good clinical practice. Global Quality Alliance Global Quality Alliance (GQA) is a 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. Global Regulatory Pharmaceutical, medical device, biotechnology, food, and nutraceutical consulting for the international markets. GLP Quality Consulting Good Laboratory Practice (GLP) consulting services for the pharmaceutical, biotech, and agricultural chemistry industries. 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. 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. HIPAA Training & Compliance Consulting Provides HIPAA training, compliance kits, manuals, disaster recovery and business continuity templates and compliance consulting services. HIPAAdirect A directory of HIPAA links HIPAATraining.com Online HIPAA training and HIPAA compliance do-it-yourself kits. Horizon Phoenix Group 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. IMI Consulting GmbH IMI Consulting GmbH is specialized in advising and implementing: strategy development, global marketing, business development, licensing, and mergers and acquisitions. Innovative Consultancy Services We are an Indian pharmaceutical consultant company established in the year 1998 and providing services in regulatory affairs, pharmaceutical dossiers, product/process development, and validation services. International Regulatory and Business Consultant Providing scientific and regulatory consultant services to the global pharmaceutical, nutritional supplement, medical device, and diagnostic product industries IPMB GmbH - Institute for Regulatory Affairs and Pharmaceutical Services Institute for regulatory affairs and pharmaceutical services located in Germany. ISOComp, Inc. ISOtrain software distributors and consultants to bring training processes into FDA compliance and provide general consulting for pharmaceutical and biotechnology companies. 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 Provider of pharmaceutical development, regulatory and business intelligence information on the Japanese pharma and medical device market. Kamm & Associates Daniel Kamm, P.E., C.Q.A., is the Principal Engineer of Kamm and Associates. He is an electronics engineer and regulatory affairs executive with over thirty years experience in the medical device business, specializes in Good Manufacturing Practices auditing, consulting, and training. Karandikar Laboratories Pvt. Ltd. Test and calibration laboratory located in India. Kemic Bioresearch Kemic Bioresearch provides consulting, research and training in the pharmaceutical sciences (pharmacokinetics, pharmacology and toxicology). Kennedy Medical Writing Service Medical writing and proofreading company. Kinesis Pharma BV Consultants in drug development. Located in the Netherlands. Kobridge Consulting Ltd Korean consultants to medical device companies for CE marking, Canadian approvals, and FDA compliance. Lachman Consultant Services Provides expert technical consultation in the areas of FDA Related Activities, Quality Control / Quality Assurance, Validation / Qualification, Stability / Expiration Dating, Research and Development of Pharmaceutical Dosage Forms, New Facilities Construction for research and development and Production to the Pharmaceutical, Biotechnology, Device, Diagnostic and Allied Health Industries 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. 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. Liquent, Inc. Established provider of regulatory report publishing and submission consulting services and software for the global life sciences community. Lorentzson FDA Consulting Services Helping with the U.S. FDA regulation, compliance and approval process, including GMP, DMF, QSR, ANDA, audit and the related publications and forms. Loyamed Inc. Provide consulting services in the areas of quality assurance and regulatory affairs. Lyons Baxley Regulatory Compliance Group Regulatory compliance consultants servicing the pharmaceutical, dietary supplement, foods, and cosmetics industries. Mandell Horwitz Consultants LLC Regulatory and scientific consulting for medical devices and other FDA-regulated products. MAPCIS Validated Labeling Solutions FDA compliant labeling and barcode systems. Software specifically developed to achieve pharmaceutical and medical device compliance. 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. Masy Systems 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 A quality assurance, regulatory, and clinical consulting firm providing services to the medical device, pharmaceutical and food industries. Medcon Taiwan, Inc. A Taiwan-based regulatory affairs consultant to the medical and life science industry Medical device consultants Consultants for FDA and internationally regulated medical device firms, specializing in submissions, compliance, warning letter responses, inspection responses, quality system compliance, auditing and training 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. Medical Device Technology Consultants - Cambridge UK MDTc is an independent consultancy to the medical devices industry. Based near Cambridge, England, MDTc helps bring products to market and comply with regulatory requirements. Medical Devices Consulting Regulatory affairs, quality assurance, custom software, and compliance contracting and consulting services. MEDIcept MEDIcept is a vertically integrated consulting firm specializing in contract engineering, quality assurance, and regulatory consulting. Medicines for Children Provides regulatory advice, pharmaceutical development, and pediatric clinical trials in Europe and abroad. Mediqol Offers a range of medical device consultancy services throughout Europe (including CE marking, regulatory and clinical trials management). Medius AG - Drug Regulatory Affairs and Development Medius is a consulting and service company based in Switzerland, engaged in regulatory affairs of pharmaceuticals, medical devices, and in vitro diagnostics. MedPharmTec Services German consultant for the pharmaceutical industry. Medprofile Regulatory affairs consulting services for Thai FDA submissions. New World Regulatory Solutions/SOOP International Regulatory, quality and technical affairs guidance for international medical diagnostic device manufacturers. nFocus Technologies ERP for Life Sciences nFocus Technologies has developed a portfolio of software solutions to meet the requirements of this highly regulated industry. Octagon Research Solutions, Inc. Offers a suite of services that span the entire clinical research and development lifecycle. 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 medical device personnel. 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. Paul Regulatory Services Limited A regulatory affairs consultancy based in the UK. Pensa Technology Solutions Inc. 21 cfr part 11 regulatory compliance of FDA pharmaceutical GMP validation for ERP life sciences computer information systems. 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. Perseus Partners 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. 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 registration in EU and CEE Offers drug and medical devices registration and maintenance in EU. Pharmaceutical Regulatory Affairs Italy - Di Renzo Situated in the center of Rome. We provide regulatory services for human and veterinary medicines, mutual recognition, cosmetics, foods, medical devices, and translations. PharmaCon GmbH Consulting in regulatory strategy for medicinal products. Pharmacovigilance and Eudravigilance Consultancy based in Italy that offers scientific services and regulatory affairs for the pharmaceutical industry. Pharmalink Consulting For all European regulatory affairs issues - CTA/IMPD submissions, regulatory compliance issues, and CMC PharmaReady PharmaReady™ is a fully integrated web-based eDMS and eCTD Submissions Solution Suite. 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. PRISYM ID Compliant Barcode & Labeling 21 CFR Part 11 validated barcode and labeling solutions for pharmaceutical and medical device manufacturers. PSF Medical European business support and authorised representative for small medical device companies. 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. QRC Associates QRC Associates provides management with cGMP and QSR advice. 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. 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. QuadraMed A pharmaceutical regulatory company with European affiliated offices specializing in marketing authorizations, European clinical trials, mutual recognition procedures, and orphan drug designations. QualiMedd 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 Medical Regulations Services Provides quality assurance documentation support. Assists in site licensing, product registration, HACCP development and implementation. Ottawa, Canada. Quality Solutions Validation Professionals, Inc. (VPI) offers a full range of validation, compliance and technical services for the pharmaceutical, biotechnology and medical device industries. Quality Systems Laboratories Provides compliance process management and eLearning products and services. Quality Vectors Provide validations, cGxP compliance, systems engineering, and quality systems to pharmaceutical, medical device, and biotechnology industries. 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. 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 systems or improving existing systems. 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. Reg-info.com A collection of links to websites with information relating to regulatory affairs and the development of medicines. RegIntel Ltd. Provides international regulatory solutions to the pharmaceutical and biologics industries. Regulatory Affairs Associates LLC RAA (regulatory affairs consultancy) Regulatory Affairs Consulting Regulatory affairs consulting services to the pharmaceutical and related industries. Regulatory Affairs, North America LLC Regulatory affairs consultancy headquartered in North Carolina. 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. 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). Regulatory Consultants Perfect Consultants is an association of pharmaceutical experts providing regulatory consultation to the pharmaceutical industries in the development of dossiers, Drug Master Files (DMFs), and Common Technical Documents (CTDs). 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. Regulatory Services Co., Inc. Regulatory affairs and quality assurance consulting for entrepreneurial medical device companies. RegulatoryPro.com RegulatoryPro offers regulatory affairs consulting services to the biopharmaceutical, medical device and other FDA-regulated industries. 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. Samarind Regulatory Management Software Samarind RMS is a software package for the pharmaceutical industry that manages regulatory affairs and licence submissions. SDCS Consultant and advocate for the medical device industry on issues of regulatory and standards compliance, risk management (ISO 14971) and general device safety. 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. Seraphim Life Sciences Consulting LLC Seraphim provides integrated consulting and due diligence on regulatory and operations issues for life sciences companies and investors. Shafi Consultancy Firm specializing in providing SAS training and expertise in working with clinical trials. Sigma Biomedical Sigma Biomedical supports biomedical research and medical device development by providing custom solutions. SimPILy Read Offers patient information leaflet readability tests, compliance reviews and advice on leaflet improvement for international pharmaceutical and traditional herbal medicines industries. 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. Smith and Associates A consulting firm specializing in regulatory affairs for medical device manufacturing. Spherelink FDA Consulting Spherelink provides FDA consulting and international trade consulting between Asia and the United States. Strategic Compliance International, Inc. SCI, Inc. specializes in regulatory compliance consulting for biologics, medical devices and drug companies. 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). Tarius A/S Provides the pharmaceutical, biologics and medical device industries with regulatory and compliance information. Includes services provided, company news and events. TDC Software TDC Software is an engineering software suite covering risk management. Tecno-med Ingenieros Located in Barcelona, Spain - helps manufacturers to obtain CE mark for their medical devices. 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. Torrington Gower Consultants Regulatory affairs consultants specializing in CMC/ Clinical National (UK and IE) submissions (renewals and variations). TRAC Services A UK based company providing regulatory affairs consultancy and patient information leaflet user testing to the pharmaceutical industry. 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. 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 partner search. UNICUS REGULATORY SERVICES Unicus regulatory services is a European consultancy with experience in all aspects of regulatory affairs and pharmacovigilance. Validation and cGMP Compliance Equipment and Software Validation. Part 11 of 21 CFR Compliance. Regulations, cGMP, Validation knowledge base. FDA Warning letters. 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 Solutions Ltd Validation and compliance services for the Pharmaceutical Industry. Specialists in computer systems validation and electronic records and signatures. 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. Validation Technologies, Inc. Worldwide validation, quality, compliance, and production services for the medical device, pharmaceutical, nutraceutical, and biotechnology industries. Veirup Consult Danish regulatory affairs consultancy VTS Consultants, Inc. Validation and regulatory consulting services for the pharmaceutical, biotechnology, and medical device industries. 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. WellKang LLC Regulatory affairs consultancy specializing in medical devices. Westerwald-Institute German consulting group experienced in different licensing procedures of drugs and medicinal products at the national and European level. Website is available in both German and English. 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 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, India 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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