http://www.gmp-online-consultancy.com
Description?: Good Manufacturing Practice GMP Online Consultancy for 483, FDA Inspections, Pre Approval Inspections PAI, Quality Assurance
- Keywords?:
- GMP Online Consultancy, Good Manufacturing Practice, 483, PAI, Pre Approval Inspection, Quality Assurance, Regulatory Requirements, SOP, Standard Operation Procedure, FDA, Validation Master Plan, Warning letter
- Author?:
- www.gmp-online-consultancy.com
- Copyright?:
- www.gmp-online-consultancy.com
- Doctype?:
- html PUBLIC "-//W3C//DTD XHTML 1.0 Transitional//EN" "http://www.w3.org/TR/xhtml1/DTD/xhtml1-transitional.dtd"
- Character set?:
- utf-8
- Language?:
- not provided
- Robots?:
- all
- Generator?:
- not provided
- Size of the HTML file?:
- 36538 Byte
http://www.prisymidinc.com
Description?: 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.
- Keywords?:
- barcode software, 21, cfr, part, 11, FDA, GMP, cGMP, regulatory compliance, clinical trials, pharmaceutical validation, pharmaceutical packaging, food traceability, labeling software, labeling systems, PRISYM ID Inc, PRISYMID
- Author?:
- PRISYM ID Inc.
- Copyright?:
- PRISYM ID Inc.
- Doctype?:
- HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN" "http://www.w3.org/TR/html4/loose.dtd"
- Character set?:
- ISO-8859-1
- Language?:
- not provided
- Robots?:
- ALL
- Generator?:
- not provided
- Size of the HTML file?:
- 26065 Byte
http://www.carexa.com
Description?: Carexa Inc. provides outsourcing for regulatory services. President: Jan Sedgeworth
- Keywords?:
- Jan Sedgeworth, biotechnology, regulatory consultant, regulatory outsource services, drug development, regulatory affairs
- Author?:
- Sari Heiber-McLenaghan of InfoClear Internet Consulting for Carexa Inc.
- Copyright?:
- This page and all of it's content are copyrighted 2003 by Carexa Inc.
- Doctype?:
- HTML PUBLIC "-//W3C//DTD HTML 4.0 Transitional//EN"
- Character set?:
- iso-8859-1
- Language?:
- not provided
- Robots?:
- all
- Generator?:
- not provided
- Size of the HTML file?:
- 5241 Byte
http://www.obelis.net/
Description?: Obelis European Representative provides CE Marking consultation for medical device manufacturers and high quality european authorized representative services
- Keywords?:
- European Authorized Representative, European Authorized, directive emc, 89/336/eec, IVD directive, MDD, gpsd, 93/42 EEC, 98/79/EC, LVD Directive, Notified body, GPSD, USAgent, EMC Directive, 98/79/ec, gpsd directive, 93/42 EEC, European Authorised Representative, US Agent, 76/768/eec, European Authorized, Notified body, authorized, EU directives, ec declaration conformity, ISO 9001:2000, ...
- Author?:
- European Authorized Representative
- Copyright?:
- not provided
- Doctype?:
- HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"
"http://www.w3.org/TR/html4/loose.dtd"
- Character set?:
- iso-8859-1
- Language?:
- en
- Robots?:
- index,follow
- Generator?:
- not provided
- Size of the HTML file?:
- 21123 Byte
http://www.risk-online.com
Description?: 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.
- Keywords?:
- risk-analysis, DIN 14971, risk-management, medical-devices, In-Vitro-Diagnostics, IVD, IVD, In, vitro-Diagnostics, FDA, marking, risk, analysis, FDA, authorization, CE-marking, EN 1441, Qware Riskmanager, seminars, software, post prodution information, marking, certification, notified body, product lifecycle
- Author?:
- www.bayoo.net
- Copyright?:
- www.bayoo.net
- Doctype?:
- HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"
- Character set?:
- utf-8
- Language?:
- de
- Robots?:
- index,follow
- Generator?:
- not provided
- Size of the HTML file?:
- 24873 Byte
http://www.drumkey.com
Description?: 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
- Keywords?:
- clinical trial supplies, DRUMBEAT® method, DRUMBEAT®, Drumbeat Dimensions, drumkey, compliance, FDA, document management, computer system validation, procedures, cGMP, GMPs, intellectual property, regulations, consultant, regulation, industry, industries, standards, regulatory affairs, consulting, SOPs, GXP, GCP, GLP, regulatory, process validation, pharmaceutical industry manufacturing, ...
- Author?:
- Mark Fields, Webmaster,http://www.drumkey.com
- Copyright?:
- Copyright© 1999-2005, Drumbeat Dimensions, Inc. All rights reserved.
- Doctype?:
- HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"
"http://www.w3.org/TR/html4/loose.dtd"
- Character set?:
- iso-8859-1
- Language?:
- not provided
- Robots?:
- index,follow
- Generator?:
- not provided
- Size of the HTML file?:
- 8531 Byte
http://www.medpharmtec.de
Description?: Your slogan here
- Keywords?:
- News, news, New, new, Technology, technology, Headlines, headlines, Nuke, nuke, PHP-Nuke, phpnuke, php-nuke, Geek, geek, Geeks, geeks, Hacker, hacker, Hackers, hackers, Linux, linux, Windows, windows, Software, software, Download, download, Downloads, downloads, Free, FREE, free, Community, community, MP3, mp3, Forum, forum, Forums, forums, Bulletin, bulletin, Board, board, Boards, boards, PHP, ...
- Author?:
- MedPharmTec - Services
- Copyright?:
- Copyright (c) by MedPharmTec - Services
- Doctype?:
- HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"
- Character set?:
- ISO-8859-1
- Language?:
- not provided
- Robots?:
- INDEX, FOLLOW
- Generator?:
- PHP-Nuke - Copyright by http://phpnuke.org
- Size of the HTML file?:
- 12535 Byte
http://www.arazygroup.com
Description?: The Arazy Group Web Site
- Keywords?:
- ArazyGroup, Medical Equipment, Consultant, ISO 9001, FDA, CE, QSR
- Author?:
- Underline-Studios.com
- Copyright?:
- All rights reserved ArazyGroup LTD. 2001 (C)
- Doctype?:
- HTML PUBLIC "-//W3C//DTD HTML 3.2 Final//EN"
- Character set?:
- iso-8859-8
- Language?:
- not provided
- Robots?:
- not provided
- Generator?:
- not provided
- Size of the HTML file?:
- 8599 Byte
http://www.FDALive.com
Description?: FDALive.com-We Bring the FDA to You
- Keywords?:
- IDE, 510K, FDA Advisory committees, clinical trials, Device panels, drug approval, drug approvals, drugs, Efficacy, FDA, FDA Advisory Committee, Investigational, New, Drug, (IND), medical devices, NDA, New Drug Application(NDA), Premarket Application (PMA), Urology, vaccines, 1FDA, FDA, FDA Satellite, FDA Videoconferencing, FDA Videoconference, FDA Videoconferences, FDA Webcast, FDA Webcasting, ...
- Author?:
- Video On Location, Inc.
- Copyright?:
- Copyright © 2004 Video On Location, Inc. All Rights Reserved.
- Doctype?:
- not provided
- Character set?:
- iso-8859-1
- Language?:
- not provided
- Robots?:
- index, nofollow
- Generator?:
- not provided
- Size of the HTML file?:
- 32133 Byte
http://www.bestechconsulting.biz
Description?: BesTech: FDA consulting, medical device consulting, product development, and product safety. Expertise in medical diagnostic imaging.
- Keywords?:
- fda consulting, ce-marking, medical device, medical device consulting, regulatory, regulatory consulting, product development, device consulting, medical equipment, medical device safety, product safety, bestech
- Author?:
- Nicolaas C. Besseling
- Copyright?:
- 1996-2005 Dutchwork Inc., dba BesTech Consulting Services
- Doctype?:
- html PUBLIC "-//W3C//DTD XHTML 1.0 Transitional//EN"
"http://www.w3.org/TR/xhtml1/DTD/xhtml1-transitional.dtd"
- Character set?:
- iso-8859-1
- Language?:
- not provided
- Robots?:
- all
- Generator?:
- not provided
- Size of the HTML file?:
- 6107 Byte
http://www.510k.us/510k-submission-procedure.html
Description?: 510k- FDA 510(k) Submission Procedure: Introduction - Services offered by Wellkang LLC
- Keywords?:
- FDA, 510k, 510(k), premarket, notification, premarket notification, submission, process, procedure, UL, ce marking, ce mark, ce-marking, ccc, CCC Mark, Wellkang, LLC, Wellkang LLC, regulatory, consultancy, China Compulsory Certification, China, Compulsory, Certification, mark, mark, trade, export, import, market, trade mark, Wellkang AB, Wellkang Ltd, Wellkang Tech Consulting, ...
- Author?:
- Wellkang Marketing - www.wellkang.net
- Copyright?:
- not provided
- Doctype?:
- HTML PUBLIC "-//W3C//DTD HTML 4.01//EN"
"http://www.w3.org/TR/html4/strict.dtd"
- Character set?:
- iso-8859-1
- Language?:
- not provided
- Robots?:
- ALL
- Generator?:
- not provided
- Size of the HTML file?:
- 16388 Byte
http://www.brandtconsulting.us
Description?: 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.
- Keywords?:
- clinical quality assurance, gcp consulting, harrisonburg virginia, quality assurance services, clinical research auditing, GCP auditing, QA auditing, clinical compliance, FDA regulations, ICH Guidelines, pharmaceutical research, GCP compliance, GCP training, ICH guidelines, Gwyneth Brandt, GMP compliance
- Author?:
- not provided
- Copyright?:
- not provided
- Doctype?:
- HTML PUBLIC "-//W3C//DTD HTML 4.0 Transitional//EN"
- Character set?:
- ISO-8859-1
- Language?:
- not provided
- Robots?:
- index,follow
- Generator?:
- not provided
- Size of the HTML file?:
- 2008 Byte
http://www.complianceassociates.ca
Description?: Providing Practical and Economical solutions to the Life Sciences Industry - Computer system validation professionals
- Keywords?:
- compliance, associates, intro, practical, economical, life sciences, industry, pharmaceutical, pharma, solutions, computer system validation
- Author?:
- not provided
- Copyright?:
- not provided
- Doctype?:
- HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"
"http://www.w3.org/TR/html4/loose.dtd"
- Character set?:
- iso-8859-1
- Language?:
- not provided
- Robots?:
- not provided
- Generator?:
- not provided
- Size of the HTML file?:
- 1114 Byte
http://www.aqapress.com
Description?: 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.
- Keywords?:
- iso 9000, iso 9001, iso 14000, iso 14001, qs-9000, qs9000, qs 9000, iso 13485, iso 13488, iso9000:2000, iso 9000:2000, iso 9000/2000, iso 9000: 2000, iso 9000-2000, ISO/TS 16949, ISO/TS 16949:2002, TS 16949, TS16949, ts16949, ts 16949, iso 9000 information, iso 14000 information, qs 9000 information, iso 9000 software, iso 14000 software, qs 9000 software, iso 9000 documentation, ...
- Author?:
- not provided
- Copyright?:
- not provided
- Doctype?:
- HTML PUBLIC "-//W3C//DTD HTML 4.0 Transitional//EN"
- Character set?:
- iso-8859-1
- Language?:
- not provided
- Robots?:
- not provided
- Generator?:
- not provided
- Size of the HTML file?:
- 15033 Byte
http://www.fda-consultant.com
Description?: Fda-consultant.com provides cost effective FDA regulatory affairs services world wide.
- Keywords?:
- not provided
- Author?:
- not provided
- Copyright?:
- not provided
- Doctype?:
- HTML PUBLIC "-//W3C//DTD HTML 4.0 Transitional//EN"
- Character set?:
- iso-8859-1
- Language?:
- not provided
- Robots?:
- not provided
- Generator?:
- Microsoft FrontPage 4.0
- Size of the HTML file?:
- 18373 Byte
http://www.mdtconsultants.co.uk/
Description?: 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
- Keywords?:
- medical, devices, quality, systems, assurance, project, management, FDA, surveillance, submissions, regulatory, 510(k), 510k, PMA, ISO 9000, ISO 13485, regulation, CE mark, strategy, compliance
- Author?:
- not provided
- Copyright?:
- not provided
- Doctype?:
- HTML PUBLIC "-//W3C//DTD HTML 4.01 Frameset//EN"
- Character set?:
- iso-8859-1
- Language?:
- not provided
- Robots?:
- not provided
- Generator?:
- not provided
- Size of the HTML file?:
- 2335 Byte
http://www.seerpharma.com.au
Description?: 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.
- Keywords?:
- Pharmaceutical, GMP, Validation, Consulting, Training, E-learning, Computer, Audit, Compliance, Quality, Assurance, Software, GLP, Services, GAMP, Australia, Biotechnology, Clinical, Device, Regulatory, TGA, FDA
- Author?:
- not provided
- Copyright?:
- not provided
- Doctype?:
- HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"
- Character set?:
- iso-8859-1
- Language?:
- not provided
- Robots?:
- not provided
- Generator?:
- not provided
- Size of the HTML file?:
- 10014 Byte
http://devicecompliance.com/
Description?: 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.
- Keywords?:
- China, UL, CSA, 2601-1, 60601-1, Europe, MDD, FDA, medical device, regulation, regulatory, compliance, litigation, standards, global, risk management, 14971, Mike, Schmidt, essential performance, EMC, 60601-1-2, 60601-1-6, training, strategic, medical, device, regulation, regulatory, compliance, litigation, standards, global, standard, risk, risk management, 60601-1, 14971, Mike, Schmidt, ...
- Author?:
- Mike Schmidt
- Copyright?:
- not provided
- Doctype?:
- html public "-//IETF//DTD HTML 4.0//EN"
- Character set?:
- iso-8859-1
- Language?:
- not provided
- Robots?:
- not provided
- Generator?:
- Microsoft Publisher 2000
- Size of the HTML file?:
- 30856 Byte
http://www.mapcis.com
Description?: 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.
- Keywords?:
- bar code software, barcode software, RFID systems, RFID technology, labelling software, labeling software, labelling systems, 21, cfr, part, 11, FDA, GMP, cGMP, regulatory compliance, thermal transfer labels, thermal transfer ribbons, custom labels, thermal transfer printers, barcode printers, labelling equipment, clothing labels, MAP 80, MAP80, MAPCIS, MAPCIS Inc, prisymgroup
- Author?:
- not provided
- Copyright?:
- MAPCIS
- Doctype?:
- html PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"
- Character set?:
- ISO-8859-1
- Language?:
- not provided
- Robots?:
- ALL
- Generator?:
- not provided
- Size of the HTML file?:
- 25590 Byte
http://www.21cfrpart11.com
Description?: 21 CFR Part 11:Your FDA Compliance,Electronic Records, Electronic Signatures,cGMP and Meta Data Resource
- Keywords?:
- 21, cfr, part, 11, 21cfrpart11, 21cfr, 21cfr11, 21cfr 11, electronic records, electronic signatures, meta data, archive, 21, cfr, part, 11, 21cfrpart11, cgmp, fda, compliance, gmp, gxp, glp, gcp, cgmp, computer validation, validation, fd, plc, scada, process control, fda, signatures, signature rule, pharmaceutical, galp, audit trail, batch records, best practices, data management, ...
- Author?:
- not provided
- Copyright?:
- not provided
- Doctype?:
- HTML PUBLIC "-//W3C//DTD HTML 3.2 Final//EN"
- Character set?:
- windows-1252
- Language?:
- not provided
- Robots?:
- not provided
- Generator?:
- not provided
- Size of the HTML file?:
- 8988 Byte
http://www.biologicsconsulting.com
Description?: 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.
- Keywords?:
- biologics consulting, consulting services, food, and, drug, administration, FDA, regulatory compliance, biologics, regulatory affairs, Center, for, Biologics, Evaluation, and, Research, CBER, Center, for, Drug, Evaluation, and, Research, CDER, pharmacology, toxicology, guidance, guidelines, Virginia, California, North Carolina, product management, FDA policies, clinical, inspections, audits, ...
- Author?:
- not provided
- Copyright?:
- not provided
- Doctype?:
- HTML PUBLIC "-//W3C//DTD HTML 4.0 Transitional//EN"
- Character set?:
- ISO-8859-1
- Language?:
- not provided
- Robots?:
- not provided
- Generator?:
- MSHTML 6.00.2716.2200
- Size of the HTML file?:
- 10972 Byte
http://www.consultifarma.com
Description?: 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...
- Keywords?:
- vigilância sanitária, medicamentos, registro, consultoria, assessoria, salmerón, indústria farmacêutica, autorização de funcionamento, ANVISA, ministério, da, saúde, VISA, controle de qualidade, secretaria de saúde, pesquisa, inspeção, CIVISA, treinam ento, marketing, marketing farmacêutico, ...
- Author?:
- Paulo Fink
- Copyright?:
- not provided
- Doctype?:
- html PUBLIC "-//W3C//DTD XHTML 1.0 Transitional//EN" "http://www.w3.org/TR/xhtml1/DTD/xhtml1-transitional.dtd"
- Character set?:
- iso-8859-1
- Language?:
- not provided
- Robots?:
- all
- Generator?:
- not provided
- Size of the HTML file?:
- 10620 Byte
http://yourFDAconsultant.com
Description?: 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.
- Keywords?:
- Estrin, Norman Estrin, ECG, Medical Device, Consulting, FDA, Food, and, Drug, Administration, 510, 510(k), 510k, IDE, Premarket Approval, PMA, Product Development Protocol, PDP, Premarket Clearance, Regulatory Submissions, Cosmetics, Labeling
- Author?:
- Melissa K. Estrin
- Copyright?:
- not provided
- Doctype?:
- HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"
- Character set?:
- iso-8859-1
- Language?:
- not provided
- Robots?:
- not provided
- Generator?:
- Dreamweaver 2
- Size of the HTML file?:
- 3518 Byte
http://spherelink.com
Description?: Spherelink provides FDA consulting and international trade consulting between Asia and the United States.
- Keywords?:
- 'FDA consulting', 'FDA compliance', 'trade consulting', USDA, 'united states', asia, korea, japan
- Author?:
- not provided
- Copyright?:
- not provided
- Doctype?:
- html PUBLIC "-//W3C//DTD XHTML 1.0 Transitional//EN" "http://www.w3.org/TR/xhtml1/DTD/xhtml1-transitional.dtd"
- Character set?:
- UTF-8
- Language?:
- not provided
- Robots?:
- not provided
- Generator?:
- not provided
- Size of the HTML file?:
- 6066 Byte
http://www.GlobalRegulatory.com
Description?: 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.
- Keywords?:
- regulatory consulting, pharmaceutical attorneys, medical device attorneys, nutraceutical attorneys, dietary supplements attorneys, regulatory consultants, medical device consultants, medical device consulting, pharmaceuticals consultants, pharmaceutical consulting, biopharmaceutical consultants, biopharmaceutical consulting, food consulting, food consultants, nutraceutical consultants, ...
- Author?:
- not provided
- Copyright?:
- not provided
- Doctype?:
- HTML PUBLIC "-//W3C//DTD HTML 4.0 Transitional//EN"
- Character set?:
- iso-8859-1
- Language?:
- not provided
- Robots?:
- not provided
- Generator?:
- not provided
- Size of the HTML file?:
- 55896 Byte
http://www.iso-13485.com
Description?: ISO 13485 quality manual, including procedures,forms and and/or training for small business …
- Keywords?:
- iso 13485, medical devices, 2003, quality manual, training, quality management systems
- Author?:
- not provided
- Copyright?:
- not provided
- Doctype?:
- html PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"
- Character set?:
- windows-1252
- Language?:
- not provided
- Robots?:
- not provided
- Generator?:
- not provided
- Size of the HTML file?:
- 9815 Byte
http://www.schwoebel.net
Description?: Medical Device Executive with successful launch of over 100 products. Experience with product planning, clinical studies, regulatory affairs, reimbursement strategy and HIPAA.
- Keywords?:
- Regulatory Affairs, medical device, regulatory affairs, FDA, Schwoebel
- Author?:
- Joe Schwoebel
- Copyright?:
- Joe Schwoebel
- Doctype?:
- HTML PUBLIC "-//W3C//DTD HTML 4.0 Transitional//EN"
- Character set?:
- windows-1252
- Language?:
- not provided
- Robots?:
- index,follow
- Generator?:
- MSHTML 6.00.2900.2523
- Size of the HTML file?:
- 10609 Byte
http://www.liquent.com
Description?: Liquent is the world?fs leading provider of content assembly, regulatory publishing, and regulatory intelligence solutions for the Life Sciences industry.
- Keywords?:
- Regulatory publishing, regulatory intelligence, dossier publishing, submission publishing, submission management, NDA publishing, report publishing, eCTD, CTD, electronic, Common, Technical, Document, Common Technical Document, IDRAC, CoreDossier, Core Dossier, XML rendering, PDF rendering, XML publishing, XML conversions, Word to PDF, Word to XML, Convert to XML, Convert to PDF, SVG Conversion, ...
- Author?:
- The Strategies Group - http://www.strategies.co.uk/
- Copyright?:
- not provided
- Doctype?:
- HTML PUBLIC "-//W3C//DTD HTML 4.0 Transitional//EN"
- Character set?:
- iso-8859-1
- Language?:
- not provided
- Robots?:
- not provided
- Generator?:
- not provided
- Size of the HTML file?:
- 24303 Byte
http://www.omsbar.com/
Description?: 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.
- Keywords?:
- omsbar, medical consultancy, medical device, iso 10993, biocompatibility, schematic capture, simulation, pcb design, embedded microprocessor, FDA QMS, FMECA, proof-of principle, regulatory affairs, equivalence assessment, product registrations, export certification, training, project management, product development, iec60601-1, iec60601-1-1, iec60601-2 (emc), iec60601-4, iec60601-2-x, ...
- Author?:
- not provided
- Copyright?:
- not provided
- Doctype?:
- HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"
"http://www.w3.org/TR/html4/loose.dtd"
- Character set?:
- iso-8859-1
- Language?:
- not provided
- Robots?:
- INDEX,FOLLOW
- Generator?:
- not provided
- Size of the HTML file?:
- 8507 Byte
http://www.pharmalinkconsulting.co.uk
Description?: Pharmalink Consulting specialise in regulatory affairs supplying professional consultants and contractors.
- Keywords?:
- Regulatory affair, Regulatory affairs consultant, Regulatory affairs contractors, Reg affairs, reg. Consultant, reg. Contractors, mca, fda, bira, esra, Pharmaceutical contractors, Pharmaceutical training, pharmaceutical specialist, pharma training, European specialists, Worldwide, bibliographic, biotechnology, chemistry & pharmacy, preclinical trials
- Author?:
- Pharmalink Consulting
- Copyright?:
- not provided
- Doctype?:
- HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"
- Character set?:
- iso-8859-1
- Language?:
- en-gb
- Robots?:
- index,follow
- Generator?:
- not provided
- Size of the HTML file?:
- 3993 Byte
http://www.qualityfirstint.com
Description?: International medical devices regulatory consultancy
- Keywords?:
- medical, device, consultancy, devices, regulatory, affairs
- Author?:
- not provided
- Copyright?:
- not provided
- Doctype?:
- HTML PUBLIC "-//W3C//DTD HTML 4.01//EN" "http://www.w3.org/TR/html4/strict.dtd"
- Character set?:
- windows-1252
- Language?:
- not provided
- Robots?:
- not provided
- Generator?:
- Microsoft FrontPage 4.0
- Size of the HTML file?:
- 3423 Byte
http://www.reg-info.com/
Description?: reg-info.com is a collection of links to web sites with information relating to regulatory affairs and the regulation of medicines
- Keywords?:
- regulatory, regulatory affairs, CPMP, CHMP, FDA, CDER, CBER, arbitration, medicines, EMEA, MHRA, MCA, Europe, European, pharmaceutical, global, development
- Author?:
- Tim Felgate
- Copyright?:
- not provided
- Doctype?:
- not provided
- Character set?:
- windows-1252
- Language?:
- not provided
- Robots?:
- not provided
- Generator?:
- not provided
- Size of the HTML file?:
- 8979 Byte
http://www.regintel.com
Description?: Regulatory Intelligence for the BioPharma Industry.
- Keywords?:
- regulatory, intelligence, pharmaceutical, drug, biologic, biopharmaceutical, law, guideline, liquent, idrac, fda
- Author?:
- not provided
- Copyright?:
- not provided
- Doctype?:
- HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"
- Character set?:
- UTF-8
- Language?:
- not provided
- Robots?:
- not provided
- Generator?:
- not provided
- Size of the HTML file?:
- 9199 Byte
http://www.validationmasters.com/
Description?: Validation Masters Inc., a full service Validation company serving the Pharmaceutical manufacturing and Clinical Research Industries.
- Keywords?:
- validation, pharmaceutical, biotechnology, SOP, computer, FDA, regulatory, regulation, 21, CFR, Part 11, qualification, consulting, Validation Masters
- Author?:
- Daniel Khordi, Validation Masters, Inc.
- Copyright?:
- not provided
- Doctype?:
- HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"
"http://www.w3.org/TR/html4/loose.dtd"
- Character set?:
- ISO-8859-1
- Language?:
- not provided
- Robots?:
- nofollow
- Generator?:
- not provided
- Size of the HTML file?:
- 6778 Byte
http://www.northvail.com
Description?: 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.
- Keywords?:
- 1&1, 1and1, web hosting, domain names, domain name, web site, website hosting, web design, domain name registration, small business, ecommerce, cheap web hosting, webmaster, web site builder, web space, affordable web hosting, microsoft hosting, linux hosting, hosting, domain, server, sharepoint hosting, frontpage hosting
- Author?:
- not provided
- Copyright?:
- 2005, 1and1.com
- Doctype?:
- html
PUBLIC "-//W3C//DTD HTML 4.01//EN" "http://www.w3.org/TR/html40/strict.dtd"
- Character set?:
- UTF-8
- Language?:
- not provided
- Robots?:
- not provided
- Generator?:
- not provided
- Size of the HTML file?:
- 6302 Byte
http://www.buzzeopdma.com
Description?: 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.
- Keywords?:
- BuzzeoPDMA, buzzeo, FDA Consulting, PDMA, PDMA Compliance, PDMA Consulting, DEA, DEA Consulting, CSA, Diversion, Controlled Substances, Drug Samples, Inventory, Reconciliation, Auditing, Compliance, State Regulatory Requirements
- Author?:
- not provided
- Copyright?:
- not provided
- Doctype?:
- HTML PUBLIC "-//W3C//DTD HTML 4.0 Transitional//EN"
- Character set?:
- ISO-8859-1
- Language?:
- not provided
- Robots?:
- not provided
- Generator?:
- not provided
- Size of the HTML file?:
- 27102 Byte
http://www.unicus.co.uk/
Description?: Unicus - Specialising in regulatory strategy, planning, training and all aspectsof regulatory application, preparation and filing.
- Keywords?:
- Unicus, regulatory affairs, pharmaceutical regulatory services, clinical reports, medicines, biotechnology, medicine licensing, Uk, Berkshire, Consultant, Regulatory affairs contractors, Reg affairs, reg.
Consultant, Pharmaceutical training, pharmaceutical specialist, European specialists, bibliographic, biotechnology, chemistry & pharmacy, preclinical trials, clinical trial, CTD, ...
- Author?:
- not provided
- Copyright?:
- not provided
- Doctype?:
- html PUBLIC "-//W3C//DTD XHTML 1.0 Transitional//EN" "http://www.w3.org/TR/xhtml1/DTD/xhtml1-transitional.dtd"
- Character set?:
- iso-8859-1
- Language?:
- en-gb
- Robots?:
- index,follow
- Generator?:
- not provided
- Size of the HTML file?:
- 16554 Byte
http://www.pharma-con.ch/index2.html
Description?: consulting in regulatory strategy for medicinal products;
- Keywords?:
- pharmacontext, pharmaceutical, regulatory, affairs, services, medicinal products, switzerland, pharmaceutical industry, maa, MAA, variation, variations, standard operating procedures, sop, sops, second loop applications, psur, ctd, CTD Format, pharmacovigilance, haldenstrasse 1 baar, regina bauckhage, katrin dürr, duerr, lucia kürzi, kuerzi
- Author?:
- not provided
- Copyright?:
- not provided
- Doctype?:
- not provided
- Character set?:
- iso-8859-1
- Language?:
- not provided
- Robots?:
- not provided
- Generator?:
- www.cm4all.com
- Size of the HTML file?:
- 7612 Byte
http://www.21CFRPart11Compliance.com
Description?: 21 CFR Part 11 Compliance Software Solutions
- Keywords?:
- 21, CFR, Part, 11, ISO 9000, FDA, GLP, GCP, GMP, Excel Version Control, Word Version Control, Document Control, eLab Notebook, Electronic Lab Notebook, Digital Laboratory Notebook, Sciex, Sciex API, API 3000, API 4000, API 5000, Thermo Finnigan, Finnigan, TSQ, TSQ-7000, Plate Reader, Molecular Devices, Bioinformatics, informatics, Laboratory Network
- Author?:
- not provided
- Copyright?:
- not provided
- Doctype?:
- HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"
- Character set?:
- not provided
- Language?:
- not provided
- Robots?:
- index
- Generator?:
- Microsoft FrontPage 4.0
- Size of the HTML file?:
- 9459 Byte
http://www.accuratefdaconsulting.com
Description?: Accurate Consultants provides expert consulting services to the FDA regulated industry, which need help in various quality, compliance, and regulatory areas.
- Keywords?:
- Accurate Consultants, FDA Consultants, US Agent, FDA Auditing, Services, QSR Training, Training for Auditors, FDA Compliance Services, Quality System Implementation, Regulatory Submissions, GMP Training, Good Manufacturing Services, FDA QSIT Audits, FDA 483 Responses, Warning Letter Responses, 510k Submissions, IDE Submissions
- Author?:
- Paul Hartsuyker
HARTWORKS
paul@hartworks.net
619-269-8939
- Copyright?:
- not provided
- Doctype?:
- HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"
- Character set?:
- iso-8859-1
- Language?:
- not provided
- Robots?:
- not provided
- Generator?:
- not provided
- Size of the HTML file?:
- 6254 Byte
http://www.alphapharma.com/aboutus.html
Description?: Good Manufacturing Practice, GMP, consulting services to manufacturers of pharmaceutical formulations, active pharmaceutical ingredients and biotechnology products
- Keywords?:
- GMP, Good Manufacturing Practice, consulting, pharmaceutical, biotechnology, api, active pharmaceutical ingredient, quality systems, quality control, good laboratory practice, glp, quality management, validation, qualification
- Author?:
- not provided
- Copyright?:
- not provided
- Doctype?:
- HTML PUBLIC "-//W3C//DTD HTML 4.01//EN"
"http://www.w3.org/TR/html4/strict.dtd"
- Character set?:
- iso-8859-1
- Language?:
- not provided
- Robots?:
- all
- Generator?:
- not provided
- Size of the HTML file?:
- 7032 Byte
http://www.appliedregulatory.com
Description?: Applied Regulatory Consulting offers a wide range of regulatory consultancy services to companies seeking help with the development of pharmaceutical products.
- Keywords?:
- appeals, applications, approval, arbitration, authorisation, authorization, centralised, centralized, CHMP, clinical trials, common technical document, consultancy, consultant, CPMP, CTA, CTD, CTX, development, drug, EMEA, Europe, European, hearings, IND, interim management, MAA, marketing authorisation application, marketing authorisation applications, marketing authorization application, ...
- Author?:
- not provided
- Copyright?:
- not provided
- Doctype?:
- HTML PUBLIC "-//W3C//DTD HTML 4.0 Transitional//EN"
- Character set?:
- windows-1252
- Language?:
- not provided
- Robots?:
- not provided
- Generator?:
- not provided
- Size of the HTML file?:
- 8810 Byte
http://www.entrinsik.com
Description?: Informer is the market leading web reporting tool for IBMs Universe and Unidata dbms systems; Semtek is event management software for continuing education, training and conference producers; Athena is an ideal web based software tool for corporate event managers.
- Keywords?:
- U2 Web Reporting, Datatel Reporting, Keystone Reporting, Universe Reporting, Unidata Reporting, Web Reporting, event management, event planning, reporting tool, reporting solution, registration system, seminar management software, Semtek, conference management software, learning management system, continuing, education, management, system, program management, fulfillment management, ...
- Author?:
- not provided
- Copyright?:
- not provided
- Doctype?:
- HTML PUBLIC "-//W3C//DTD HTML 4.0 Transitional//EN"
- Character set?:
- not provided
- Language?:
- not provided
- Robots?:
- not provided
- Generator?:
- not provided
- Size of the HTML file?:
- 13557 Byte
http://FDACompliance.Net
Description?: FDACompliance.Net is provide a central location for all your regulatory compliance needs.
- Keywords?:
- regulatory compliance, code, of, federal, regulations, fda warning letters, FDA Regulations, FDA Guidance, 21 CFR, 21, CFR, Part, 11, GMP, GXP, GCP, GLP
- Author?:
- not provided
- Copyright?:
- not provided
- Doctype?:
- HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"
"http://www.w3.org/TR/html4/loose.dtd"
- Character set?:
- windows-1252
- Language?:
- not provided
- Robots?:
- not provided
- Generator?:
- Microsoft FrontPage 5.0
- Size of the HTML file?:
- 6638 Byte
http://www.fdacompliancesolutions.com
Description?: 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.
- Keywords?:
- Computer System Validation, Software Validation, Process Validation, Pharmaceutical Validation, Pharmaceutical, Consulting, Training, Seminars, Validation Training, Validation Seminars, FDA Validation, Phil Sax
- Author?:
- not provided
- Copyright?:
- not provided
- Doctype?:
- HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"
"http://www.w3.org/TR/html4/loose.dtd"
- Character set?:
- iso-8859-1
- Language?:
- not provided
- Robots?:
- not provided
- Generator?:
- not provided
- Size of the HTML file?:
- 11916 Byte
http://www.mdiconsultants.com
Description?: 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
- Keywords?:
- FDA, ISO, Medical Device, 510(k) submissions, ISO 9000, ISO 9001, ISO 13485, CE mark, Medical Device, Quality, Regulatory, consulting, 510(k), 510K, PMA, GMP, MDD, IVDD, HACCP, cGMP, validation, Quality Assurance, QSR, training, audit, Pharmaceutical, U.S. Agent, marketing, fda consulting, food, clinical trials, EU authorized representative, Technical File preparation, ...
- Author?:
- not provided
- Copyright?:
- not provided
- Doctype?:
- html PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"
- Character set?:
- windows-1252
- Language?:
- not provided
- Robots?:
- Index, follow
- Generator?:
- not provided
- Size of the HTML file?:
- 16751 Byte
http://www.phoenixrising.com
Description?: FDA Consultants/Regulatory Advisors to the Pharmaceutical, Medical Device, and Food Industries. Call Phoenix Regulatory Associates, Ltd. for insightful guidance by FDA and industry experts, 703/406-0906.
- Keywords?:
- fda, fda consultants, FDA consultant, fda consultant, fda consultants, regulatory consultant, regulatory consultants, fda regulatory consultant, FDA regulatory consultants, consent decree, warning letter responses, 483 responses, form 483 responses, preclinical toxicity trials, Frank Fazzari, process validation, cleaning validation, method validation, iq, Iq, OQ, oq, Oq, PQ, pq, Pq, PQ, QA, API, ...
- Author?:
- not provided
- Copyright?:
- not provided
- Doctype?:
- HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"
"http://www.w3.org/TR/html4/loose.dtd"
- Character set?:
- ISO-8859-1
- Language?:
- not provided
- Robots?:
- all
- Generator?:
- not provided
- Size of the HTML file?:
- 11119 Byte
http://soop.us
Description?: We are seasoned professionals in Regulatory, Quality and Technical Affairs who specialize in US FDA clearances and CLIA Waivers for medical diagnostic devices. We help domestic and tnternational clients gain market approval for medical devices.
- Keywords?:
- Other, Science, &, Technology, FDA, Regulatory, Affairs, CLIA, Waiver, Quality, Assurance, Medical, Devices, Clinical, Studies, Diagnostic, Devices, FDA, Relations, Compliance, CLIA, Quality, Systems, CE, Mark, FDA, Regulations, Regulatory, Submissions, 510(k), PMA, FDA, Consultant, FDA, Approval
- Author?:
- not provided
- Copyright?:
- not provided
- Doctype?:
- not provided
- Character set?:
- not provided
- Language?:
- not provided
- Robots?:
- not provided
- Generator?:
- not provided
- Size of the HTML file?:
- 8325 Byte
http://www.harpazconsulting.com/
Description?: Providing GMP Compliance consultation, regulatory and technical expertise to manufacturers of Drug Products, Active Pharmaceutical Ingredients, and Medical Devices.
- Keywords?:
- GMP, GMP Consultant, GMP Compliance, CGMP, API and GMP, Active Pharmaceutical Ingredients, Q7A, Cleaning Validation, Process Validation, Regulatory Compliance, GMP Training, Warning Letters, Quality Systems, Pre-approval Inspections, FDA Regulatory Consultant, Clinical Trial Materials, Clinical Supplies, Drug Master File
- Author?:
- not provided
- Copyright?:
- Harpaz Consulting Services
- Doctype?:
- HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"
- Character set?:
- iso-8859-1
- Language?:
- not provided
- Robots?:
- not provided
- Generator?:
- not provided
- Size of the HTML file?:
- 15176 Byte
http://www.hdmcorp.com
Description?: HDM offers timely thorough HIPAA compliance training solutions as well as compliant
electronic claims submissions software.
- Keywords?:
- hipaa compliance, hipaa training, hipaa regulation, hipaa privacy and
confidentiality, protected healthcare information, hipaa Internet training, hipaa education, electronic claim submission
software, edi software, hippa, electronic claim filing, hipaa learning
- Author?:
- not provided
- Copyright?:
- not provided
- Doctype?:
- HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"
- Character set?:
- not provided
- Language?:
- not provided
- Robots?:
- index,follow
- Generator?:
- not provided
- Size of the HTML file?:
- 5508 Byte
This directory uses links and structure from dmoz
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