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Regulatory Affairs
Directory > Business > Business_Services > Consulting > Medical_and_Life_Sciences > Regulatory Affairs
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| Business > Business_Services > Quality_Control_and_Tracking > Consulting (229) |
| Science > Biology > Toxicology > Products_and_Services > Consultants (10) |
  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. |
21 CFR Part 11 compliant digital and electronic signatures for any file format, document system, or web application. |
21 cfr part 11 regulatory compliance of FDA pharmaceutical GMP validation for ERP life sciences computer information systems. |
provides worldwide regulatory, clinical, and quality assurance consulting services to medical device and diagnostic product manufacturers to meet US, Canadian, and European requirements. |
Validation and calibration services for the pharmaceutical, biotech, and related fields. Information on equipment and shipper studies. |
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. |
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. |
Delphi Consulting Group provides US FDA consulting services for medical devices. |
Provides quality assurance documentation support. Assists in site licensing, product registration, HACCP development and implementation. Ottawa, Canada. |
A consulting firm specializing in regulatory affairs for medical device manufacturing. |
Clinical Device Group offers full CRO services for medical devices manufacturers. |
Provide qualification, compliance, regulatory, training, and validation services to pharmaceutical, medical device, and biotechnology industries. Specializing in facility, equipment and Part 11 validations. |
Professional compliance management company dedicated to developing products and tools for assessing, enhancing, and maintaining regulatory compliance. |
Live broadcasting of FDA meetings via video-conferencing, webcasting and audio-conferencing. Post-meeting webcasts, DVD, CD's, videotapes and transcripts available. |
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. |
Spherelink provides FDA consulting and international trade consulting between Asia and the United States. |
Provides the pharmaceutical, biologics and medical device industries with regulatory and compliance information. Includes services provided, company news and events. |
We provide contract and consulting services in the following areas: validation and technical services (IQ OQ PQ protocols and validation master plans VMP), quality systems development, laboratory services, environmental monitoring, and water testing. |
RegulatoryPro offers regulatory affairs consulting services to the biopharmaceutical, medical device and other FDA-regulated industries. |
European pharmaceutical/biotech consultancy specializing in project management, medical writing, and business development. |
Worldwide validation, quality, compliance, and production services for the medical device, pharmaceutical, nutraceutical, and biotechnology industries. |
Consultant for medical device importers, manufacturers, and physicians intending to introduce medical devices into U.S. commerce. Expert witness for neurological devices. |
Regulatory affairs consultancy headquartered in North Carolina. |
Consultant and advocate for the medical device industry on issues of regulatory and standards compliance, risk management (ISO 14971) and general device safety. |
Consultants for FDA and internationally regulated medical device firms, specializing in submissions, compliance, warning letter responses, inspection responses, quality system compliance, auditing and training |
EU regulatory affairs and preclinical/toxicological consulting. |
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 |
Carexa's experienced consultants provide strategy and services for drug development and regulatory affairs. |
Applied Regulatory Consulting Limited provides regulatory consultancy to the pharmaceutical industry, including strategic regulatory consultancy, training, regulatory agency interactions, and regulatory submissions. |
Offers a suite of services that span the entire clinical research and development lifecycle. |
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. |
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. |
Provide consulting services in the areas of quality assurance and regulatory affairs. |
Offering ISO 13485 and FDA QSR (21 CFR 820) Quality Manual and Operational Procedures and forms. Free software demo downloads available. |
Regulatory affairs consulting services to the pharmaceutical and related industries. |
ISOtrain software distributors and consultants to bring training processes into FDA compliance and provide general consulting for pharmaceutical and biotechnology companies. |
Pharmaceutical, medical device, biotechnology, food, and nutraceutical consulting for the international markets. |
Validation Professionals, Inc. (VPI) offers a full range of validation, compliance and technical services for the pharmaceutical, biotechnology and medical device industries. |
Offers validation, ERP/CRM, testing, and enterprise efficiency services for medium and large scale organizations from Rockville, Maryland. |
Situated in the center of Rome. We provide regulatory services for human and veterinary medicines, mutual recognition, cosmetics, foods, medical devices, and translations. |
Regulatory compliance and validation documentation consulting for FDA-regulated drug manufacturing and testing companies worldwide. |
FDA compliance and regulatory consulting to help clients develop efficient and effective quality systems. |
Specializing in the provision of validation and CGMP (Current Good Manufacturing Practice) compliance services. |
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. |
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. |
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 |
A pharmaceutical regulatory company with European affiliated offices specializing in marketing authorizations, European clinical trials, mutual recognition procedures, and orphan drug designations. |
A directory of HIPAA links |
Seraphim provides integrated consulting and due diligence on regulatory and operations issues for life sciences companies and investors. |
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. |
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). |
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. |
Validation and compliance services for the Pharmaceutical Industry. Specialists in computer systems validation and electronic records and signatures. |
Offers Internet-based HIPAA privacy and confidentiality training software for payers, providers and academia as well as HIPAA-compliant medical billing software for providers. |
Regulatory, quality and technical affairs guidance for international medical diagnostic device manufacturers. |
Provides compliance process management and eLearning products and services. |
Regulatory consultants expediting FDA approval by solving tough scientific, clinical, and regulatory issues which may arise pre- and post-submission. |
Regulatory affairs, quality assurance, custom software, and compliance contracting and consulting services. |
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. |
Established provider of regulatory report publishing and submission consulting services and software for the global life sciences community. |
A quality assurance, regulatory, and clinical consulting firm providing services to the medical device, pharmaceutical and food industries. |
A regulatory affairs and quality systems consulting company serving the medical device and pharmaceutical industries. |
QRC Associates provides management with cGMP and QSR advice. |
Validation and regulatory consulting services for the pharmaceutical, biotechnology, and medical device industries. |
Assisting companies in the pharmaceutical, biotechnology, medical device, and diagnostic industries meet compliance and development needs. |
Equipment and Software Validation. Part 11 of 21 CFR Compliance. Regulations, cGMP, Validation knowledge base. FDA Warning letters. |
Provides international regulatory solutions to the pharmaceutical and biologics industries. |
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. |
Regulatory affairs consultancy specializing in medical devices. |
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. |
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. |
Compliance for electronic record management for FDA regulated companies. |
Atubra provides a full range of consulting services to FDA regulated industries including drug, medical device, cosmetic, and dietary supplement companies. |
Provides pharmaceutical CMC regulatory consulting services, specializing in regulatory strategic, dossier preparation, and training services. |
Unicus regulatory services is a European consultancy with experience in all aspects of regulatory affairs and pharmacovigilance. |
Medical Device RA and Quality System Consultants |
Provides compliance solutions for Healthcare and Financial Sector. |
CIEX Incorporated is dedicated to Quality Software and provides services in Software Lifecycle Processes, Software Quality Assessments, Reliable Software Design. |
Helping with the U.S. FDA regulation, compliance and approval process, including GMP, DMF, QSR, ANDA, audit and the related publications and forms. |
GCP Solutions provides good clinical practice consulting services. |
Providing a wide range of consulting services in GCP, GLP and GMP compliance. |
Offers CE marking, US agent services to non-European medical devices manufacturers under AIMD, MDD, and IVD, under EU directives from Brussels, Belgium. |
Joe Schwoebel is General Manager of Allegheny Associates. The consultancy provides services related to medical product planning, clinical study, regulatory affairs and reimbursement strategy. |
This website syndicates material for regulatory affairs professionals. Feeds are obtained from a variety of global resources about the US Food and Drug Administration. |
Consultancy based in Germany that offers scientific and regulatory services for the pharmaceutical industry. |
Consultant Group specializing in providing services on FDA Compliance Issues to the Food, Drug and Cosmetic industry. |
RAA (regulatory affairs consultancy) |
Reg123.com is a portal for the new medicinal product development community with a focus on regulatory affairs and the pharmaceutical drug development process. |
A collection of links to websites with information relating to regulatory affairs and the development of medicines. |
Clinical Consulting: Specializing in regulatory affairs, sas programming, biotechnology careers, data management companies, staffing pharmaceutical, consulting, statistics, biotechnology, sas, and cro. |
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. |
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). |
Good Manufacturing Practice (GMP) consulting services to the pharmaceutical industry. |
Consultants to medical device companies for CE marking, authorized representative, FDA compliance and CCC mark for China. Offices in US, Europe and Asia. |
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. |
Providing GMP compliance consultation, regulatory and technical expertise to manufacturers of drug products, active pharmaceutical ingredients, and medical devices worldwide. |
Privately held virtual company in Encinitas, California, offering quality and risk assesments, remediation, IT system validation and training for FDA regulated industries. |
Consultants in drug development. Located in the Netherlands. |
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. |
A resource for issues surrounding the FDA's 21 CFR Part 11 Rule on electronic records and signatures. |
Provider of pharmaceutical development, regulatory and business intelligence information on the Japanese pharma and medical device market. |
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. |
Part 11 compliance software solutions designed for MS-Excel, MS-Word, electronic laboratory notebbook, and file replication. |
European-based, Good Manufacturing Practice (GMP) Online Consultancy |
Provide mock audits, quality systems assessments, and liaison services with the FDA. |
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. |
Medius is a consulting and service company based in Switzerland, engaged in regulatory affairs of pharmaceuticals, medical devices, and in vitro diagnostics. |
CRO in drug development process in close collaboration with the preclinical and clinical departments of pharmaceutical and biotech companies. |
Located in Barcelona, Spain - helps manufacturers to obtain CE mark for their medical devices. |
Consulting in regulatory strategy for medicinal products. |
Consulting group headquartered in Belgium. They manage biosafety and biotechnology compliance requirements. |
Sigma Biomedical supports biomedical research and medical device development by providing custom solutions. |
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. |
Consultant involved with the development, purchase, installation, operation and maintenance of computerized systems used in FDA compliant applications. |
Good Laboratory Practice (GLP) consulting services for the pharmaceutical, biotech, and agricultural chemistry industries. |
TDC Software is an engineering software suite covering risk management. |
Specialized on eCTD submissions. |
Regulatory compliance consultants servicing the pharmaceutical, dietary supplement, foods, and cosmetics industries. |
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. |
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). |
Specialists in the field of pharmaceutical regulatory affairs. |
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. |
Offers drug and medical devices registration and maintenance in EU. |
Document, drawing and spreadsheet management solutions for US FDA compliant pharma manufacturing units. |
Offers patient information leaflet readability tests, compliance reviews and advice on leaflet improvement for international pharmaceutical and traditional herbal medicines industries. |
Regulatory and scientific consulting for medical devices and other FDA-regulated products. |
Korean consultants to medical device companies for CE marking, Canadian approvals, and FDA compliance. |
SCI, Inc. specializes in regulatory compliance consulting for biologics, medical devices and drug companies. |
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. |
FarmavitaR+ is a professional network of regulatory affairs consultants and professionals. |
Specializing in CE marking, services for medical devices and also for manufacturers of personal protective equipment, in vitro diagnostics and medical test laboratories. |
Cursussen Good Clinical Practice |
Danish regulatory affairs consultancy |
Provide scientific and regulatory affairs consultancy to investors, individual investigators, and the biopharmaceutical industry operating in the field of vaccinology. |
Draco Associates offers regulatory affairs consulting and quality assurance consulting and services for pharmaceuticals, natural health products, and other regulated products. |
xFDA consulting provides services to small and mid-sized pharmaceutical and device companies including biotechnology in the areas of preclinical, clinical, CMC and regulatory. |
IMI Consulting GmbH is specialized in advising and implementing: strategy development, global marketing, business development, licensing, and mergers and acquisitions. |
Emergo Group provides in-country regulatory representation to medical device companies seeking CE Marking certification in Europe. Offices in The Netherlands, US, Asia. |
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. |
Regulatory affairs consultants specializing in CMC/ Clinical National (UK and IE) submissions (renewals and variations). |
Regulatory affairs consulting services for Thai FDA submissions. |
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. |
Provides regulatory advice, pharmaceutical development, and pediatric clinical trials in Europe and abroad. |
Regulatory affairs and quality assurance consulting for entrepreneurial medical device companies. |
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. |
Firm specializing in providing SAS training and expertise in working with clinical trials. |
Specialize in regulatory consulting and authorized representation in the European Union. |
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. |
Offers a range of medical device consultancy services throughout Europe (including CE marking, regulatory and clinical trials management). |
Consultancy based in Italy that offers scientific services and regulatory affairs for the pharmaceutical industry. |
Providing scientific and regulatory consultant services to the global pharmaceutical, nutritional supplement, medical device, and diagnostic product industries |
Regulatory affairs consultants for ISO, GMP, and FDA compliance |
GCP online training course provides a comprehensive guide to the basic principles, regulations, and guidelines of ICH good clinical practice. |
Consulting services targeting compliance and performance for human tissue processors, tissue recovery organizations, organ procurement organizations, eye banks, reproductive banks, and medical device manufacturers. |
MEDIcept is a vertically integrated consulting firm specializing in contract engineering, quality assurance, and regulatory consulting. |
Medical writing and proofreading company. |
PharmaReady™ is a fully integrated web-based eDMS and eCTD Submissions Solution Suite. |
Quality and regulatory compliance consulting services for the life sciences industry. |
European business support and authorised representative for small medical device companies. |
FDA Compliance Solutions' consultants provide a full range of FDA compliance services, including computer system validation, software validation, process validation, pharmaceutical validation and consulting. |
A specialty based consulting firm specializing in a range of scientific, laboratory, quality, and validation issues within the cGMP and GLP arena. |
The integration of services and software to provide competitive compliance, quality advocacy and thought leadership. |
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. |
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. |
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. |
FDA compliant labeling and barcode systems. Software specifically developed to achieve pharmaceutical and medical device compliance. |
21 CFR Part 11 validated barcode and labeling solutions for pharmaceutical and medical device manufacturers. |
GMP consultancy in Canada, assisting global pharmaceutical, biological, medical device, natural health products, and cosmetics companies with manufacturing or regulatory compliance issues. |
Generic downloadable documents that are cGMP compliant. |
An independent consultancy providing auditing services for all aspects of clinical trials and good clinical practice. |
Advisor to pharmaceutical, biotechnology, medical device, food, dietary supplements, and legal companies. |
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. |
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. |
Dedicated to providing the Life Science industry with solutions to complex regulatory and business critical requirements. |
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. |
FDA consultants Perkins and Perkins, Inc. conduct mock FDA audits to insure Good Clinical Practice (GCP) compliance, quality assurance and FDA audit preparation. |
German consultant for the pharmaceutical industry. |
UK based regulatory affairs consultants offering a wide range of services to international companies in the pharmaceutical, medical device, nutritional and healthcare industry. |
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. |
Medical device regulatory affairs, clinical studies, quality systems, and documentation services. |
A Taiwan-based regulatory affairs consultant to the medical and life science industry |
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. |
For all European regulatory affairs issues - CTA/IMPD submissions, regulatory compliance issues, and CMC |
Provide online privacy and security HIPAA training for business associates, employers, hospitals, clinics and health plans. |
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. |
Kemic Bioresearch provides consulting, research and training in the pharmaceutical sciences (pharmacokinetics, pharmacology and toxicology). |
Lionpharm is an independent consultancy company providing all kind of regulatory affairs services covering the whole life-cycle of medicinal products in Europe. |
European Pharmaceutical Consultants (EPC), s.r.o. provides consulting services to pharmaceutical regulatory affairs professionals in the European Union. |
Bio-Pharma professionals forum. |
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. |
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. |
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. |
Provides regulatory affairs research and information for the healthcare industry. |
Provide scientific and regulatory CMC consulting services to the global pharmaceutical and biopharmaceutical industry through strategic design and implementation of different aspects. |
A UK based company providing regulatory affairs consultancy and patient information leaflet user testing to the pharmaceutical industry. |
FDA warning letter and CFR categorization and search database. |
Provide validations, cGxP compliance, systems engineering, and quality systems to pharmaceutical, medical device, and biotechnology industries. |
Provides information on the FDA’s Process Analytical Technology (PAT) Initiative and outlines a software package to help pharmaceutical manufacturers implement this initiative. |
Assists companies in biotechnology, pharmaceutical and chemical markets with business development and market analysis. |
A regulatory affairs consultancy based in the UK. |
Provide software products and consultancy expertise to help companies achieve compliant and validated syst |