eCTD/CDISC Octagon Research Solutions, Inc.
Business, Business Services, Consulting, Medical and Life Sciences - Octagon Research. Using an electronic submission system (eSub), Octagon assists clients in the achievement an approved regulatory submission.
http://www.octagonresearch.com
ISOXpress
Business, Business Services, Consulting, Medical and Life Sciences - AQA. Offering ISO 13485 and FDA QSR (21 CFR 820) Quality Manual and Operational Procedures and forms.
http://www.aqapress.com
Medical device consultants
Provides cost effective medical device consulting services for projects related to compliance with FDA regulations, FDA submissions, 510(k)s, PMAs, FDA inspection readiness, Warning Letter responses, procedures, training, auditing, client and marketing surveys
http://www.fdamaze.com
Compliance Associates - Life Science Software and Consulting Services
Business, Business Services, Consulting, Medical and Life Sciences - Compliance Associates - Life Science Software and Consulting Services. Compliance Associates is dedicated to providing the Life Science industry with solutions to complex regulatory and business critical requirements.
https://www.complianceassociates.ca/
GMP Experts
Business, Business Services, Consulting, Medical and Life Sciences - GMP Experts. Offer analysis, development, documentation, validation, support and assistance to industries regulated by FDA and similar international agencies.
http://www.gmpexperts.com/
Quality First International Medical Devices Consultancy
Business, Business Services, Consulting, Medical and Life Sciences - Quality First International Ltd.. 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.
https://www.qualityfirstint.com/
Brandt Research Consulting - GCP, GLP and GMP Consulting Services
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
Medical Device Consultant
Business, Business Services, Consulting, Medical and Life Sciences - Doctor Device Consultant. Consultant for medical device importers, manufacturers, and physicians intending to introduce medical devices into U.
http://www.doctordevice.com
FDA Regulatory Affairs Biotechnology Consultants
Business, Business Services, Consulting, Medical and Life Sciences - Biotech Consultant LLC. 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
Regulatory Affairs Associates, Inc.
Business, Business Services, Consulting, Medical and Life Sciences - Regulatory Affairs Associates LLC. RAA (regulatory affairs consultancy).
http://www.regaffairs.net