FDA, ISO, EU and CE Regulatory Affairs Consultants: FDA Advisors, RA Professionals, US Agents/Correspondents/Representatives, EU CE in California (CA) for medical companies
  FDA/ISO Regulatory Affairs Consultants
Phone: 949-481-5713
Email: info@abrimed.com
 
AREAS OF EXPERTISE
FDA 510k
PMA • NDA
Quality•GMP•ISO•CE/EU MDD
Supplements•Botanicals
Lab Testing•Clinical Trials
Risk Management
International
State Regulations
Business Start-ups
Medical, pharma (pharmaceuticals/drugs) and biotech (biotechnology) and dietary supplements
Serving Southern California CA (San Diego, Orange County and Los Angeles-LA) and Northern California CA (San Jose and San Francisco), North America (US and Canada), Europe (Germany, France, UK - EU) and Asia (China, Japan and India)
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Abrimed provides FDA consulting services for the healthcare industry. Our team of experts includes regulatory affairs professionals, product design/engineering firms and other regulatory professionals. We focus on medical product development and manufacturing, from concept through testing, clinical trials, FDA/ISO regulatory compliance and ongoing manufacturing.
Contact Abrimed Regulatory Consultants for....
  • Authorized Representatives, US Agents and Official Correspondents with the FDA
  • ISO and FDA regulatory affairs professionals
  • ISO 13485 and ISO 9001 registration and certification consultants
  • Medical device development and manufacturing engineers
  • EU CE Mark Medical Device Directive (MDD, IVDD and AIMDD) consultants
  • FDA GMP regulations, QSR and product validation specialists
  • FDA and ISO audit advisors
  • Quality systems and quality assurance (QA/QC) consulting experts
  • FDA 510k notification/submissions specialists
  • Medical product lab testing, IEC and clinical trials consultancy
  • Medical, pharma and biotech company international distribution and support
Abrimed is based in Southern California, with experience throughout North America, Europe and Asia/China.