Practical, experienced guidance in development, GMP/GTP production, and regulatory compliance. Comprehensive scientific and technical strategic analysis of commercial opportunities. Serving biotechnology companies, clinical laboratories, and biotechnology investors.

• QA/Regulatory Compliance
  • Requirements, applicability, strategy
    • FDA-CBER OCTGT, CDRH, AABB, AATB, FACT, NIH-RAC
  • Pre-IND, IND, IDE applications, amendments
  • Audits and gap analysis
  • QA system design