FDA, Good Manufacturing Practices GMP, quality system QSR, ISO 13485 regulatory consultants manufacturing development device, drug, diagnostic, combination medical products, 510(k), PMA, IDE

Research & Development -
Anticipating Regulatory Approvals

The Tamarack Group expertise draws from different disciplines in the life sciences to help minimize risks and uncertainties inherent in product development. We help clients anticipate the product characterization data required for regulatory approvals. Our advice guides product development activities with an aim toward satisfying current U.S. and international regulatory expectations for

  • Final product specifications
  • Product failure mode and effects (hazard / risk) analysis
  • Verification & validation of medical devices and diagnostics
  • Clinical trials for medical devices and diagnostics
  • Product development reports for pharma and biotech

Clients utilize our insight and experience to improve the performance and compliance of Good Clinical Practice, Design Control and Product Development programs.

See our books on Product Development and Validation !!