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Regulatory Affairs
Webpages concerning "Regulatory Affairs"
BesTech: FDA consulting, medical device consulting, product development, and product safety. Expertise in medical diagnostic imaging.
http://www.bestechconsulting.biz
Good Manufacturing Practice GMP Online Consultancy for 483, FDA Inspections, Pre Approval Inspections PAI, Quality Assurance
http://www.gmp-online-consultancy.com
Regulatory compliant barcode software and labeling systems from PRISYM ID Inc. Professional, secure and auditable labeling systems using the latest in biometric identification for electronic records and electronic signatures. Specialized, validated solutions for pharmaceutical packaging & manufacturing, medical device, clinical trials and all 21 CFR Part 11, FDA, GMP & cGMP regulated environments.
http://www.prisymidinc.com
Carexa Inc. provides outsourcing for regulatory services. President: Jan Sedgeworth
http://www.carexa.com
Obelis European Representative provides CE Marking consultation for medical device manufacturers and high quality european authorized representative services
http://www.obelis.net/
Chestnut Solutions Inc (CSI) is a global regulatory affairs and document management consulting practice serving biotech and pharmaceutical companies in Canada, Europe and the U.S. CSI helps companies shorten time-to-submission by implementing strategies related to electronic document management that support the submission and electronic submission (e-submission, e-CTD) process thus facilitating...
http://chestnutsolutions.com/
Consultoria especializada para dar suporte às empresas sujeitas à legislação sanitária em especial nas atividades junto ao trabalho com o Ministério da Saúde, ANVISA, Registro de Medicamentos,Consultoria especializada para dar suporte às empresas sujeitas à legislação sanitária vigente em especial nas atividades r...
http://www.consultifarma.com
Risk analysis according to DIN 14971 risk management for medical devices and In-Vitro-Diagnostics IVD, EN 1441 with software Qware Riskmanager, certification of medical devices and products incl. documentation post production for notified body.
http://www.risk-online.com
Drumbeat Dimensions was incorporated February 1, 1995, to answer the need of the health care industry to organize and upgrade its GMP-related policy and SOP management systems
http://www.drumkey.com
Estrin Consulting Group, Inc. (ECG) assists medical device, and cosmetic companies in complying with FDA regulatory requirements. ECG specializes in medical device regulatory submissions, and provides a broad range of regulatory services through a network of other respected experts.
http://yourFDAconsultant.com
Medical Device Executive with successful launch of over 100 products. Experience with product planning, clinical studies, regulatory affairs, reimbursement strategy and HIPAA.
http://www.schwoebel.net
Liquent is the world?fs leading provider of content assembly, regulatory publishing, and regulatory intelligence solutions for the Life Sciences industry.
http://www.liquent.com
reg-info.com is a collection of links to web sites with information relating to regulatory affairs and the regulation of medicines
http://www.reg-info.com/
We offer consultation and training on compliance with Medical Device Regulation around the world and standards including ISO/EN 14971 (risk management), the IEC/EN 60601-1 series.
http://devicecompliance.com/
Bar code software, barcode printers, RFID systems and technology. Professional, easy to use labelling systems, thermal transfer consumables and printers. Specialised barcode solutions for Chemical, Food, Textile and Life Sciences companies including 21 CFR Part 11, FDA, GMP & cGMP, medical device, pharmaceutical and clinical trial environments. Formerly known as MAP80 Systems.
http://www.mapcis.com
510k- FDA 510(k) Submission Procedure: Introduction - Services offered by Wellkang LLC
http://www.510k.us/510k-submission-procedure.html
Applied Regulatory Consulting offers a wide range of regulatory consultancy services to companies seeking help with the development of pharmaceutical products.
http://www.appliedregulatory.com
The Biologics Consulting Group LLC provides regulatory and product development advice to manufacturers of products regulated by CBER and CDER of the FDA. Our staff consists of experts in regulatory affairs product manufacturing and testing pharm/tox statistics and clinical trial design/evaluation.
http://www.biologicsconsulting.com
Providing a wide range of clinical quality assurance services in GCP, GLP and GMP compliance. Our specialty areas include GCP training, investigator site audits, vendor audits, IRB audits, document audits, and development of operating procedures.
http://www.brandtconsulting.us
Providing Practical and Economical solutions to the Life Sciences Industry - Computer system validation professionals
http://www.complianceassociates.ca
FDA Compliance Solutions' consultants provide a full range of FDA compliance services, including
Computer System Validation, Software Validation, Process Validation, Pharmaceuticacl Validation and consulting, and more.
http://www.fdacompliancesolutions.com
A quality assurance, regulatory, clinical consulting firm, mdi consultants provides services to the medical device industry, pharmaceutical industry and food industry and provider of services for U.S. Agent, CE mark, ISO 9000, FDA, Pharmaceutical and quality assurance
http://www.mdiconsultants.com
Spherelink provides FDA consulting and international trade consulting between Asia and the United States.
http://spherelink.com
Find consultants and attorneys for regulatory consulting, auditing and training in the pharmaceuticals, biopharmaceuticals, medical devices, in-vitro diagnostics, biologicals, food, beverages, dietary supplements, nutraceuticals, cosmetics, veterinary medicince, healthcare, clinical trials industries.
http://www.GlobalRegulatory.com
Innovative Consultancy Services is an Indian pharmaceutical consultant company providing services to pharmaceutical industries for Bulk drug, Bulk drugs, Drug products, Drug formulation, Pharmaceutical formulation, Drug impurity, Technical knowhow, Patent, Patent search, Regulatory affair, Regulatory compliance, Structure elucidation, Drug impurity profile, Impurity profile, Drug polymorphs, Drug ...
http://www.pharmaceutical-consultancy.com
ISO 13485 quality manual, including procedures,forms and and/or training for small business …
http://www.iso-13485.com
ISO 9000, ISO 14000, QS-9000, TS 16949, ISO 13485 and EN 46000 software, books, manuals, procedures and training materials by Jack Kanholm, published by AQA Press. 27,000 companies use these materials to prepare for certification of their quality and management systems.
http://www.aqapress.com
Fda-consultant.com provides cost effective FDA regulatory affairs services world wide.
http://www.fda-consultant.com
Pharmaceutical CMC regulatory consulting services - strategic
planning, dossier preparation, training. RAC certified. Flexible/Professional/Effective.
http://www.lewiscmc.com
MDTc is an independent consultancy to the medical devices industry. Based near Cambridge, England, we can help bring your product to market and comply with regulatory requirements
http://www.mdtconsultants.co.uk/
OMSBAR, specialist consultancy services in Regulatory Affairs, Product Registrations and Export Certification, Training, Project Management and Product Development, Quality Management, Verification and Validation and maintains a core staff of experienced medical device personnel.
http://www.omsbar.com/
Pharmalink Consulting specialise in regulatory affairs supplying professional consultants and contractors.
http://www.pharmalinkconsulting.co.uk
QuadraMed is a regulatory affairs consultancy with offices throughout Europe offering a comprehensive and personal service for all aspects of regulatory affairs within the healthcare industry.
http://www.quadramed.org.uk/
International medical devices regulatory consultancy
http://www.qualityfirstint.com
Regulatory Intelligence for the BioPharma Industry.
http://www.regintel.com
SeerPharma is Asia Pacific's leading and largest professional consultancy specializing in the delivery of GMP compliance and validation, QA knowledge and training solutions to the pharmaceutical, medical device and biotechnology industries.
http://www.seerpharma.com.au
Tarius Interactive is a world-leading pharmaceutical knowledge management system based on XML architecture.
http://www.tarius.com
Validation Services, Equipment Calibrations and Validation Equipment Rentals from Masy Systems, Inc.
Pharmaceutical validation services, equipment calibrations and validation equipment rentals from Masy Systems, Inc.
http://www.masy.com/
1&1 offers Web hosting, domain names, website builders, servers, and email solutions. Find affordable, dedicated ad-free web hosting, domain name registration and e-mail solutions. Choose 1&1 Internet to host your small business website or personal web site.
http://www.northvail.com
Barnhill & Associates, Inc. is a specialty based consulting firm that has expertise in a wide range of Scientific,
Laboratory, Quality, and Validation issues within the cGMP and GLP arena. From laboratory training and quality systems development to cleaning
validations, we have significant experience in the Pharmaceutical and Biotech industries. Our firm also offers executive recruiting as well.
O...
http://barnhillassociates.net
BuzzeoPDMA,Inc. (Buzzeo) is the recognized industry leader in assisting companies to comply with the policies of the Food and Drug Administration (FDA), the requirements of the Prescription Drug Marketing Act (PDMA), the policies of the Drug Enforcement Administration (DEA), the requirements of the Controlled Substance Act (CSA), and state pharmacy and drug control regulations.
http://www.buzzeopdma.com
Unicus - Specialising in regulatory strategy, planning, training and all aspectsof regulatory application, preparation and filing.
http://www.unicus.co.uk/
consulting in regulatory strategy for medicinal products;
http://www.pharma-con.ch/index2.html
21 CFR Part 11:Your FDA Compliance,Electronic Records, Electronic Signatures,cGMP and Meta Data Resource
http://www.21cfrpart11.com
Accurate Consultants provides expert consulting services to the FDA regulated industry, which need help in various quality, compliance, and regulatory areas.
http://www.accuratefdaconsulting.com
Good Manufacturing Practice, GMP, consulting services to manufacturers of pharmaceutical formulations, active pharmaceutical ingredients and biotechnology products
http://www.alphapharma.com/aboutus.html
The consulting firm of Schell & Associates, LLC. was formed to support client needs in regulatory, clinical, and quality during all stages of regulatory approval processes from the early product development stage through post-marketing activities. The firm is founded on technical expertise and professional integrity, and prides itself in being detailed orientated, responsive, and creative.
http://schell-associates.com
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Wikipedia-Article "Regulatory Affairs"
Regulatory Affairs (RA), also sometimes called Government Affairs, is a profession within regulated industries, such as pharmaceuticals, medical devices, energy, and banking. Regulatory Affairs professionals usually have responsibility for the following general areas:
- Ensuring that their companies comply with all of the regulations and laws pertaining to their business.
- Working with federal, state, and local regulatory agencies and personnel on specific issues affecting their business. i.e. working with such agencies as the Food and Drug Administration (pharmaceuticals and medical devices), The Department of Energy, or the Securities and Exchange Commission (banking).
- Advising their companies on the regulatory aspects and climate that would affect proposed activities. i.e. describing the "regulatory climate" around issues such as the promotion of prescription drugs and Sarbanes-Oxley compliance.
The regulatory professional typically has a background relevant to the business in which they work, i.e., science, law, or engineering.
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