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
 
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
INDUSTRIES
Serving the following life science and healthcare related industries:
  • Biotechnology, Biological Research, Gene Therapy
  • Clinical Diagnostics, Clinical Labs and Diagnostic Instrumentation
  • Cosmetics
  • Dietary Supplements, Alternative Medicine, Natural/Herbal Therapies and Botanicals
  • Hospitals and Healthcare Facilities
  • In Vitro Diagnostics (IVD)
  • Laboratories (Biological Research, Clinical, etc.)
  • Medical Device Manufacturing: Class I, II, III Medical Disposables and Surgical Instruments. Specialties include urology, cardiology, ophthalmology and neurology.
  • Pharmaceuticals and generic drugs
  • US Government (FDA, USDA) and State Regulations (California, etc)
  • International: EU (ISO Standards and CE Marking) and Asia (China, India and Japan)
Directory