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

Commercial Manufacturing and Testing -
Improve your Operation and Maintain Compliance

The industry knowledge base and client-interactive methods of The Tamarack Group help drive growth and improve competitive advantages. Clients make significant strategic decisions based on our independent recommendations. Our knowledge- and experience-based gap analyses identify opportunities and strategies for improvement in –

  • Document and record management systems
  • Change control and discrepancy management programs
  • Root cause investigations and action planning
  • Global corporation policies for centralized and de-centralized controls
  • Quality Management and GMP Systems
  • Compliance
  • Operations staff and management expertise
  • Annual product and quality system reviews

The Tamarack Group consultants increase your institutional knowledge and readiness for commercial production and market introduction.

See our book on Risk Management !!