Web  |  Images  |  Video  |  Mp3  |  News  |  Jobs  |  Directory
 
 

181 sites in Regulatory Affairs

Leading Rpo Specialist Save
Recruitment Process Outsourcing SME Pre Ipo Software, Service Sector.
www.cphconsulting.co.uk (sponsored link)
 
" Save
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).
http://www.bureaucracy.com.ua   
21 CFR Part 11 Save
OSR Solutions strongly believes that Computer Validation and Part 11 Compliance should not be a series of point solutions only addressing regulatory risk but is a significant opportunity for business transformation to streamline Operations through enabling technology"
http://www.osrsolutions.com/osr_solut...   
Associates Save
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.
http://www.tcolonna.com   
Associates Save
Daniel Kamm, P.E., C.Q.A., is the Principal Engineer of Kamm & 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.
http://www.fda-consultant.com   
Associates, Inc. - Pharmaceutical Consultants Save
Barnhill & Associates, Inc. is a specialty based consulting firm specializing in a wide range of scientific, laboratory, quality, and validation issues within the cGMP and GLP arena.
http://barnhillassociates.net   
Compliance Consulting Save
Provides HIPAA training, compliance kits, manuals, disaster recovery & business continuity templates and compliance consulting services.
http://www.training-hipaa.net   
Information Services, LLC Save
Provides regulatory affairs research and information for the healthcare industry.
http://www.drw-research.com   
Labeling Save
21 CFR Part 11 validated barcode and labeling solutions for pharmaceutical and medical device manufacturers.
http://www.prisymidinc.com   
Management Technology Save
Assists companies in biotechnology, pharmaceutical and chemical markets with business development and market analysis.
http://www.cbdmt.com   
21 CFR Consulting Save
Privately held virtual company in Encinitas, California, offering quality and risk assesments, remediation, IT system validation and training for FDA regulated industries.
http://www.21cfrconsulting.com/   
21 CFR Part 11 Compliance Resource Save
A resource for issues surrounding the FDA's 21 CFR Part 11 Rule on electronic records and signatures.
http://www.21cfrpart11.com   
21 CFR Part 11 Compliance Software Solutions Save
Part 11 compliance software solutions designed for MS-Excel, MS-Word, electronic laboratory notebbook, and file replication.
http://www.21cfrpart11compliance.com/   
A. Arham Associates Save
Pharma regulatory affairs consultants based in New Delhi, India for the department of DCGI - Drugs Controller General of India - & NPPA - National Pharmaceutical Pricing Authority.
http://arhamconsultants.com   
ADN - IT Compliance Expertise for FDA regulated industries Save
Compliance for electronic record management for FDA regulated companies.
http://www.adneurope.com   
AQA Save
Offering ISO 13485 and FDA QSR (21 CFR 820) Quality Manual and Operational Procedures and forms. Free software demo downloads available.
http://www.aqapress.com   
ARX - Digital Signature Solutions Save
21 CFR Part 11 compliant digital and electronic signatures for any file format, document system, or web application.
http://www.arx.com   
ARx Pharmaceutical Regulatory Consultancy LLC Save
Provide scientific and regulatory CMC consulting services to the global pharmaceutical and biopharmaceutical industry through strategic design and implementation of different aspects.
http://www.arxpharma.com/   
ASG Inc. Save
Clinical Consulting: Specializing in regulatory affairs, sas programming, biotechnology careers, data management companies, staffing pharmaceutical, consulting, statistics, biotechnology, sas, and cro.
http://www.asg-inc.com   
ATC Corp. - American Technical Consultants Save
Consultant Group specializing in providing services on FDA Compliance Issues to the Food, Drug and Cosmetic industry.
http://www.atccorp.net/   
Accurate FDA Consultants Save
FDA compliance and regulatory consulting to help clients develop efficient and effective quality systems.
http://www.accuratefdaconsulting.com   
Acerna Inc. Save
GMP consultancy in Canada, assisting global pharmaceutical, biological, medical device, natural health products, and cosmetics companies with manufacturing or regulatory compliance issues.
http://www.acerna.ca   
Advanced Quality and Regulatory Medical Save
Medical device regulatory affairs and quality system consultants with experience in FDA and CE regulations, pre-audits, and submissions.
http://www.aqrmedical.com   
Aitheras, LLC. Save
Offers validation, ERP/CRM, testing, and enterprise effeciency services for medium and large scale organizations from Rockville, Maryland.
http://www.aitheras.com/   
Allegheny Associates - Regulatory and Clinical Affairs Consulting Save
Joe Schwoebel is General Manager of Allegheny Associates. The consultancy provides services related to medical product planning, clinical study, regulatory affairs and reimbursement strategy.
http://www.schwoebel.net   
Alphapharma Consulting Save
Good Manufacturing Practice (GMP) consulting services to the pharmaceutical industry.
http://www.alphapharma.com/aboutus.html   
Applied Regulatory Consulting Save
Applied Regulatory Consulting Limited provides regulatory consultancy to the pharmaceutical industry, including strategic regulatory consultancy, project management, training, regulatory agency interactions and regulatory submissions.
http://www.appliedregulatory.com   
Arvin Shroff Associates LLC Save
Advisor to pharmaceutical, biotechnology, medical device, food, dietary supplements, and legal companies.
http://www.arvinshroff.com   
Atubra Inc. Save
Atubra provides a full range of consulting services to FDA regulated industries including drug, medical device, cosmetic, and dietary supplement companies.
http://atubra.com   
BesTech regulatory consulting Save
BesTech consulting services guides medical companies through the FDA and CE compliance processes to ensure their business success. We provide solutions for regulatory compliance, product safety, litigation support and design & development of medical devices.
http://www.bestechconsulting.biz   
Bio-Reg Associates, Inc. Save
Regulatory consulting firm assisting medical device, biologic, pharmaceutical, and biotech manufacturers meet US and international regulatory requirements.
http://www.bioreg.com   
Biologics Consulting Group- Regulatory Affairs Consultants for Manufacturers of biological products Save
Our staff of consultants has over 200 years total 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.
http://www.biologicsconsulting.com   
Biotech Consultant LLC Save
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.
http://www.biotech-consultant.com   
Brandt Research Consulting LLC Save
Providing a wide range of consulting services in GCP, GLP and GMP compliance.
http://www.brandtconsulting.us   
Bryn Mawr Partners Save
Systems integration and delivery specialists for regulatory compliant quality management applications including CAPA, complaint, electronic submission, and document management systems.
http://www.brynmawrpartners.com   
BuzzeoPDMA, Inc. Save
PDMA Compliance Auditing Service, Reconciliation Services, Field Inventory & System Auditing Services and Validation, State Requirements & Licensing, DEA Regulatory & Operational Solutions, Training, Security Vulnerability Assessment (SVA)
http://www.buzzeopdma.com   
CATS Consultants Save
EU regulatory affairs and preclinical/toxicological consulting.
http://www.catsconsultants.com   
CIEX, Incorporated Save
CIEX Incorporated is dedicated to Quality Software and provides services in Software Lifecycle Processes, Software Quality Assessments, Reliable Software Design.
http://www.ciexinc.com   
CL Tech Inc. Save
Provide qualification, compliance, regulatory, training, and validation services to pharmaceutical, medical device, and biotechnology industries. Specializing in facility, equipment and Part 11 validations.
http://www.qualityleader.com   
CMAC Consultancy Save
Provides services like documentation and change control, validation and qualification execution, calibration and preventive maintenance, GXP training & implementation, project administration and commissioning, as well as, IT services/operation management.
http://www.cmacusa.com   
Carexa Inc. Regulatory Consultants Save
Carexa's experienced consultants provide strategy and services for drug development and regulatory affairs.
http://www.carexa.com   
Ceutical Labs Save
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.
http://www.ceuticallabs.com   
Chestnut Solutions Inc. Save
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.
http://chestnutsolutions.com/   
Clinical Device Group Inc. Save
Clinical Device Group offers full CRO services for medical devices manufacturers.
http://www.clinicaldevice.com   
Clinical and Nonclinical Overviews for Pharmaceuticals Save
Consultancy based in Germany that offers scientific and regulatory services for the pharmaceutical industry.
http://www.pharmanalysis.de   
Coastal Consulting Group, Ltd. Save
Medical device regulatory affairs, clinical studies, quality systems, and documentation services.
http://www.coastalcg.com   
Coda Corp. USA Save
Regulatory compliance and validation documentation consulting for FDA-regulated drug manufacturing and testing companies worldwide.
http://www.codacorpusa.com/   
Coding Compliance Solutions Save
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.
http://codingcompliance.com   
Compliance Associates - Life Science Software and Consulting Services Save
Compliance Associates is dedicated to providing the Life Science industry with solutions to complex regulatory and business critical requirements.
http://www.complianceassociates.ca   
Compliance Control Ltd. Save
Provide software products and consultancy expertise to help companies achieve compliant and validated systems.
http://www.compliance-control.com   
ComplianceFDA, Inc. Save
FDA warning letter and CFR categorization and search database.
http://www.complianceFDA.com/   
Comply - Quality Management Software Save
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.
http://www.comply.co.il   
Computer Validation Resource Center Save
Dedicated to computer validation in the pharmaceutical industry.
http://www.gentweb.net/compval/   
Consultifarma Save
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.
http://www.consultifarma.com   
Corporate Consulting Enterprises, LLC Save
Provide mock audits, quality systems assessments, and liaison services with the FDA.
http://fdaperspective.com   
Creative Consultants India Save
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.
http://www.creativeconsultantsindia.com   
Cro.nu Save
CRO in drug development process in close collaboration with the preclinical and clinical departments of pharmaceutical and biotech companies.
http://www.cro.nu   
Delphi Consulting Save
Delphi Consulting Group provides US FDA consulting services for medical devices.
http://www.delphiconsulting.com   
Di Renzo Regulatory Affairs Save
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.
http://www.pharmaflash.com   
Directory of information for pharmaceutical regulatory affairs Save
reg-info.com is a personal collection of links to important sites relating to pharmaceutical regulatory affairs
http://www.reg-info.com/   
Doctor Device Consultant Save
Consultant for medical device importers, manufacturers, and physicians intending to introduce medical devices into U.S. commerce. Expert witness for neurological devices.
http://www.doctordevice.com/   
Draco Associates Ltd. Save
Draco Associates offers regulatory affairs consulting and quality assurance consulting and services for pharmaceuticals, natural health products, and other regulated products.
http://www.dracoassociates.com   
Drumbeat Dimensions Inc. Save
Professional compliance management company dedicated to developing products and tools for assessing, enhancing, and maintaining regulatory compliance.
http://www.drumkey.com   
ERA Consulting Group Save
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.
http://www.eraconsulting.com   
Ehrreich Consulting, Inc. Save
Regulatory consultants expediting FDA approval by solving tough scientific, clinical, & regulatory issues which may arise pre- and post-submission.
http://www.regsolutions.com   
Emergo Group Save
Consultants to medical device companies for CE marking, authorized representative, FDA compliance and CCC mark for China. Offices in US, Europe and Asia.
http://www.emergogroup.com   
Enterprise Risk and Compliance Management Save
Provides compliance solutions for Healthcare and Financial Sector.
http://azilon.com   
Entrinsik Save
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.
http://www.entrinsik.com   
Estrin Consulting Group, Inc. Save
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.
http://yourfdaconsultant.com/   
European Authorized Representative Save
Offers CE marking, US agent services to non-European medical devices manufacturers under AIMD, MDD, and IVD, under EU directives from Brussels, Belgium.
http://www.obelis.net/   
European Pharmaceutical Consultants Save
European Pharmaceutical Consultants (EPC), s.r.o. provides consulting services to pharmaceutical regulatory affairs professionals in the European Union.
http://www.pharma-eu.com   
FDA Advisors with scientific and technical expertise Save
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.
http://www.phoenixrising.com   
FDA Compliance Solutions Save
FDA Compliance Solutions' consultants provide a full range of FDA compliance services, including computer system validation, software validation, process validation, pharmaceutical validation and consulting.
http://www.fdacompliancesolutions.com   
FDACompliance.Net Save
Provides Members with searchable databases as well as full text searching of regulatory compliance topics.
http://fdacompliance.net/   
FDALive.com Save
Live broadcasting of FDA meetings via video-conferencing, webcasting and audio-conferencing. Post-meeting webcasts, DVD, CD's, videotapes and transcripts available.
http://www.fdalive.com/   
FDC Services Save
A regulatory affairs and quality systems consulting company serving the medical device and pharmaceutical industries.
http://fdcservices.com   
GCP Auditing Services Save
An independent consultancy providing auditing services for all aspects of clinical trials and good clinical practice.
http://www.gcp-auditing.com   
GCP Solutions Save
GCP Solutions provides good clinical practice consulting services.
http://mysite.verizon.net/sisbill1/gc...   
GMP Experts Save
Offer analysis, development, documentation, validation, support and assistance to industries regulated by FDA and similar international agencies.
http://www.gmpexperts.com/   
GMP Online Consultancy Save
European-based, Good Manufacturing Practice (GMP) Online Consultancy
http://www.gmp-online-consultancy.com   
Gamp Forum Save
Bio-Pharma professionals forum.
http://www.gampforum.com   
Global Regulatory Save
Pharmaceutical, medical device, biotechnology, food, and nutraceutical consulting for the international markets.
http://www.globalregulatory.com/   
HDM Corp. Save
Offers Internet-based HIPAA privacy and confidentiality training software for payers, providers and academia as well as HIPAA-compliant medical billing software for providers.
http://www.hdmcorp.com   
HIPAAdirect Save
A directory of HIPAA links
http://www.hipaadirect.com/   
Harpaz Consulting Services Save
Providing GMP compliance consultation, regulatory and technical expertise to manufacturers of drug products, active pharmaceutical ingredients, and medical devices worldwide.
http://www.harpazconsulting.com/   
Horizon Phoenix Group-Medical Quality Consulting Firm Save
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.
http://www.horizonphoenix.biz   
IDEC Validation Ltd Save
Provider of Quality & Compliance services to the Pharmaceutical / Biotechnology sector. Primarily assist organisations in the CSV field satisfy Regulatory and Compliance requirements. IVL has extensive field knowledge in the implementation of compliance solutions.
http://www.idecvalidation.com/   
ISO 13485 Quality Manual Save
Pre-written ISO 13485 quality manual, procedures, and forms for small business.
http://www.iso-13485.com   
ISOComp, Inc. Save
ISOtrain software distributors and consultants to bring training processes into FDA compliance and provide general consulting for pharmaceutical and biotechnology companies.
http://www.isocomp.com/   
Innovative Consultancy Services Save
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.
http://www.pharmaceutical-consultancy...   
Jouhou Koukai Services Save
Provider of pharmaceutical development, regulatory and business intelligence information on the Japanese pharma and medical device market.
http://www.jouhoukoukai.com   
Karandikar Laboratories Pvt. Ltd. Save
Test and calibration laboratory located in India.
http://www.laboratorytestingindia.com   
Kemic Bioresearch Save
Kemic Bioresearch provides consulting, research and training in the pharmaceutical sciences (pharmacokinetics, pharmacology and toxicology).
http://www.kemic.com   
Kinesis Pharma BV Save
Consultants in drug development. Located in the Netherlands.
http://www.kinesis-pharma.com/index2.htm   
Lachman Consultant Services Save
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 R&D and Production to the Pharmaceutical, Biotechnology, Device, Diagnostic and Allied Health Industries
http://www.lachmanconsultants.com   
Leonard Steinborn Consulting, LLC Save
Provide FDA related regulatory submission, training, auditing and consulting services.
http://www.leonardsteinbornconsulting...   
Leonard T. Flynn Save
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.
http://www.drflynnconsulting.com   
Lewis CMC Consulting Save
Provides pharmaceutical CMC regulatory consulting services, specializing in regulatory strategic, dossier preparation, and training services.
http://www.lewiscmc.com   
Lionpharm Regulatory Consulting GmbH Save
Lionpharm is an independent consultancy company providing all kind of regulatory affairs services covering the whole life-cycle of medicinal products in Europe.
http://www.lionpharm.com   
Liquent, Inc. Save
Established provider of regulatory report publishing and submission consulting services and software for the global life sciences community.
http://www.liquent.com   
Lorentzson FDA Consulting Services, FDA Publications and Forms Save
Helping with the U.S. FDA regulation, compliance and approval process, including GMP, DMF, QSR, ANDA, audit and the related publications and forms.
http://www.clorentzson.com/   
Loyamed Inc. Save
Provide consulting services in the areas of quality assurance and regulatory affairs.
http://www.loyamed.com   
MAPCIS Validated Labeling Solutions Save
FDA compliant labeling and barcode systems. Software specifically developed to achieve pharmaceutical and medical device compliance.
http://www.mapcis.com   
MDI Consultants Save
A quality assurance, regulatory, and clinical consulting firm providing services to the medical device, pharmaceutical and food industries.
http://www.mdiconsultants.com   
Marion Weinreb and Associates, Inc. Save
Assisting companies in the pharmaceutical, biotechnology, medical device, and diagnostic industries meet compliance and development needs.
http://gmpsrus.com   
Masy Systems Save
Validation and calibration services for the pharmaceutical, biotech, and related fields. Information on equipment and shipper studies.
http://www.masy.com/   
MedFO, Inc. - Medical Information Communication Consulting Save
Specialty consulting firm that focuses almost exclusively upon the strategy, operations, and functions of departments that fall under the Medical Affairs umbrella.
http://www.medfoinc.com   
MedPharmTec Services Save
German consultant for the pharmaceutical industry.
http://www.medpharmtec.de   
Medcon Taiwan, Inc. Save
A Taiwan-based regulatory affairs consultant to the medical and life science industry
http://www.medcon-taiwan.com   
Medical Device Consultants, Inc. (MDCI) Save
provides worldwide regulatory, clinical, and quality assurance consulting services to medical device and diagnostic product manufacturers to meet US, Canadian, and European requirements.
http://www.mdci.com   
Medical Device Technology Consultants - Cambridge UK Save
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.
http://www.mdtconsultants.co.uk/   
Medical Devices Consulting Save
Regulatory affairs, quality assurance, custom software, and compliance contracting and consulting services.
http://www.qsrhelp.com   
Medical device consultants Save
Consultants for FDA and internationally regulated medical device firms, specializing in submissions, compliance, warning letter responses, inspection responses, quality system compliance, auditing and training
http://www.fdamaze.com   
Medius AG - Drug Regulatory Affairs and Development Save
Medius is a consulting and service company based in Switzerland, engaged in regulatory affairs of pharmaceuticals, medical devices, and in vitro diagnostics.
http://www.medius-ag.ch   
New World Regulatory Solutions/SOOP International Save
Regulatory, quality and technical affairs guidance for international medical diagnostic device manufacturers.
http://soop.us   
Newland GxP Consultancy Save
European pharmaceutical GxP Consultancy.
http://www.newland-gxp.co.uk   
OMSBAR Save
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.
http://www.omsbar.com/   
Octagon Research Save
Using an electronic submission system (eSub), Octagon assists clients in the achievement an approved regulatory submission.
http://www.octagonresearch.com   
PAT toolkit Save
Provides information on the FDA’s Process Analytical Technology (PAT) Initiative and outlines a software package to help pharmaceutical manufacturers implement this initiative.
http://www.pattoolkit.com   
PRI Group Save
Provides specialist advice for regulatory strategy in Europe.
http://www.pri-group.com   
Paul Regulatory Services Limited Save
A regulatory affairs consultancy based in the UK.
http://www.paulrs.co.uk   
Pensa Technology Solutions Inc. Save
21 cfr part 11 regulatory compliance of FDA pharmaceutical GMP validation for ERP life sciences computer information systems.
http://www.gmps.com/   
Perkins and Perkins Save
FDA consultants Perkins and Perkins, Inc. conduct mock FDA audits to insure Good Clinical Practice (GCP) compliance, quality assurance and FDA audit preparation.
http://www.perkinsandperkins.net   
Perseus Partners Save
Consulting group headquartered in Belgium. They manage biosafety and biotechnology compliance requirements.
http://www.perseus.be   
PharmaCon GmbH Save
Consulting in regulatory strategy for medicinal products.
http://www.pharma-con.ch/index2.html   
Pharmaceutical Development Group Save
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.
http://www.pharmdevgroup.com   
Pharmaceutical Regulatory Affairs Italy - Di Renzo Save
Situated in the center of Rome. We provide regulatory services for human and veterinary medicines, mutual recognition, cosmetics, foods, medical devices, and translations.
http://www.direnzo.biz   
Pharmalink Consulting Save
For all European regulatory affairs issues - CTA/IMPD submissions, regulatory compliance issues, and CMC
http://www.pharmalinkconsulting.co.uk   
PinneyAssociates Save
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.
http://www.pinneyassociates.com/   
Q-NET LLC Save
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.
http://www.ce-authorizedrepresentativ...   
QRC Associates Save
QRC Associates provides management with cGMP and QSR advice.
http://www.qrcassociates.com   
QSite Save
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.
http://www.qsitemed.com   
Qserve Group Save
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.
http://www.qservegroup.com/   
QuadraMed Save
A pharmaceutical regulatory company with european affiliated offices specializing in marketing authorizations, european clinical trials, mutual recognition procedures, and orphan drug designations.
http://www.quadramed.org.uk/   
Quality First International Ltd. Save
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
http://www.qualityfirstint.com   
Quality Medical Regulations Services Save
Provides quality assurance documentation support. Assists in site licensing, product registration, HACCP development and implementation. Ottawa, Canada.
http://www.qmrs.com/   
Quality Solutions Save
Validation Professionals, Inc. (VPI) offers a full range of validation, compliance and technical services for the pharmaceutical, biotechnology and medical device industries.
http://www.validationprofessionals.com   
Quality Systems Laboratories Save
Provides compliance process management and eLearning products and services.
http://www.qslabs.com   
Quality Vectors Save
Provide validations, cGxP compliance, systems engineering, and quality systems to pharmaceutical, medical device, and biotechnology industries.
http://www.quality-vectors.com   
Quality management/Risk management for health care with the software-system Qware Riskmanager Save
Qware Riskmanager is the market leading quality 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.
http://www.risk-online.com   
R. A. Q .A. Associates Save
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.
http://www.raqaassociates.com   
RS Consultant Services Save
Offering consulting services to Canada and USA in dealing with regulations for medical devices and pharmaceuticals.
http://www.rsconsultantservices.com/   
Reg123.com Save
Reg123.com is a portal for the new medicinal product development community with a focus on regulatory affairs and the pharmaceutical drug development process.
http://www.reg123.com   
RegIntel Ltd. Save
Provides international regulatory solutions to the pharmaceutical and biologics industries.
http://www.regintel.com   
Regulatory Affairs Associates LLC Save
RAA (regulatory affairs consultancy)
http://www.regaffairs.net   
Regulatory Affairs Consultants to Pharmaceutical, Medical Device, Nutritional and Healthcare Industr Save
UK based regulatory affairs consultants offering a wide range of services to international companies in the pharmaceutical, medical device, nutritional and healthcare industry.
http://wainwrightassociates.co.uk   
Regulatory Affairs Consulting Save
Regulatory affairs consulting services to the pharmaceutical and related industries.
http://www.newdrugapprovals.com   
Regulatory Affairs Syndicator Save
This website syndicates material for regulatory affairs professionals. Feeds are obtained from a variety of global resources about the US Food and Drug Administration.
http://regulatory.schwoebel.net   
Regulatory Affairs, North America LLC Save
Regulatory affairs consultancy headquartered in North Carolina.
http://www.ranallc.com   
RegulatoryPro.com Save
RegulatoryPro offers regulatory affairs consulting services to the biopharmaceutical, medical device and other FDA-regulated industries.
http://www.regulatorypro.com   
SDCS Save
Consultant and advocate for the medical device industry on issues of regulatory and standards compliance, risk management (ISO 14971) and general device safety.
http://devicecompliance.com/   
SMB Validation and Compliance Services Group Save
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.
http://www.smbvalidation.com/   
Sagaem Save
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.
http://www.sagaem.it   
Samarind Regulatory Management Software Save
Samarind RMS is a software package for the pharmaceutical industry that manages regulatory affairs and licence submissions.
http://www.samarindrms.co.uk   
SeerPharma Save
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.
http://www.seerpharma.com.au   
Seraphim Life Sciences Consulting LLC Save
Seraphim provides integrated consulting and due diligence on regulatory and operations issues for life sciences companies and investors.
http://www.seraphimlifesciences.com/   
Smith and Associates Save
A consulting firm specializing in regulatory affairs for medical device manufacturing.
http://www.fdaconsultants.com/   
Spherelink FDA Consulting Save
Spherelink provides FDA consulting and international trade consulting between Asia and the United States.
http://spherelink.com   
Strategic Compliance International, Inc. Save
SCI, Inc. specializes in regulatory compliance consulting for biologics, medical devices and drug companies.
http://www.sci-nc.com   
TDC Software Save
TDC Software is an engineering software suite covering risk management.
http://www.tdc.fr/en/products/tdc_fme...   
THINQ Compliance Ltd. Save
The integration of services and software to provide competitive compliance, quality advocacy and thought leadership.
http://www.thinqcompliance.com/   
TRAC Services Save
A UK based company providing regulatory affairs consultancy and patient information leaflet user testing to the pharmaceutical industry.
http://www.tracservices.co.uk/   
Tarius A/S Save
Provides the pharmaceutical, biologics and medical device industries with regulatory and compliance information. Includes services provided, company news and events.
http://www.tarius.com/   
Tecno-med Ingenieros Medical Technologies Consultants Save
Located in Barcelona, Spain - helps manufacturers to obtain CE mark for their medical devices.
http://www.tecno-med-ingenieros.eu   
The Arazy Group Save
Medical Device RA and Quality System Consultants
http://www.arazygroup.com   
The Matthews Consultancy Save
European pharmaceutical/biotech consultancy specializing in project management, medical writing, and business development.
http://tmconsultancy.com   
The Tamarack Group Save
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).
http://www.thetamarackgroup.net   
UK Medical Device Consultancy Save
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.
http://www.medicaldeviceconsultancy.c...   
VTS Consultants, Inc. Save
Validation and regulatory consulting services for the pharmaceutical, biotechnology, and medical device industries.
http://www.vtsconsultants.com   
Valid Ground Save
Valid Ground offers services to cover most aspects of Good Clinical Practice compliance initiatives. We serve pharmaceutical, biotech, and medical device companies, academic institutions, institutional review boards, and contract research organizations.
http://www.validground.com   
Validation Online Net Save
Generic downloadable documents that are cGMP compliant.
http://www.validation-online.net   
Validation Solutions Ltd Save
Validation and compliance services for the Pharmaceutical Industry. Specialists in computer systems validation and electronic records and signatures.
http://www.validation-solutions.com   
Validation Systems, Inc. Save
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.
http://www.validationsystems.com   
Validation Technologies, Inc. Save
Worldwide validation, quality, compliance, and production services for the medical device, pharmaceutical, nutraceutical, and biotechnology industries.
http://www.validation.org/   
Validation and cGMP Compliance Save
Equipment and Software Validation. Part 11 of 21 CFR Compliance. Regulations, cGMP, Validation knowledge base. FDA Warning letters.
http://www.cqionline.com/   
Validation in Partnership Ltd Save
Specializing in the provision of validation and CGMP (Current Good Manufacturing Practice) compliance services.
http://www.vipltd.co.uk   
WellKang LLC Save
Regulatory affairs consultancy specializing in medical devices.
http://www.510k.us/510k-submission-pr...   
Westerwald-Institute Save
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.
http://members.aol.com/wwinstitut   
eHIPAA Training Save
Provide online privacy and security HIPAA training for business associates, employers, hospitals, clinics and health plans.
http://www.ehipaatraining.com   
nFocus Technologies ERP for Life Sciences Save
nFocus Technologies has developed a portfolio of software solutions to meet the unique requirements of this highly regulated industry.
http://www.nfocustechnologies.com/ind...   
unicus regulatory services Save
Unicus regulatory services is a fully functional regulatory consultancy located in the UK.