181 sites in Regulatory Affairs
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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
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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
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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
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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
AQA
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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
ASG Inc.
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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
Acerna Inc.
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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
Atubra Inc.
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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
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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
Biotech Consultant LLC
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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
BuzzeoPDMA, Inc.
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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
CL Tech Inc.
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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
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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
Ceutical Labs
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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
Consultifarma
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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
Cro.nu
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CRO in drug development process in close collaboration with the preclinical and clinical departments of pharmaceutical and biotech companies.
http://www.cro.nu
ERA Consulting Group
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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
Entrinsik
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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
FDALive.com
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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/
HDM Corp.
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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
IDEC Validation Ltd
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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/
ISOComp, Inc.
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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/
Lachman Consultant Services
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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
Medical device consultants
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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
OMSBAR
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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/
PAT toolkit
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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
Pharmaceutical Development Group
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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
QSite
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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
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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
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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/
R. A. Q .A. Associates
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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
Reg123.com
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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
SDCS
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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/
Sagaem
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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
SeerPharma
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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
Tarius A/S
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Provides the pharmaceutical, biologics and medical device industries with regulatory and compliance information. Includes services provided, company news and events.
http://www.tarius.com/
Valid Ground
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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 Systems, Inc.
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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