FDA Consulting Services for Labs
Pharmaceutical labs and dietary supplement labs are heavily regulated by the FDA.
Our FDA consultants (who are former FDA employees or have extensive industry experience) have the expertise to make the FDA regulatory and compliance process go smoothly for laboratories.
Our FDA consulting services and FDA training for labs include:
- GMP audits (Good Manufacturing Practice)
- Part 58 audits (for non-clinical laboratories)
- contract analyses
- lab SOPs (Standard Operating Procedures)
- Lab equipment validations and calibrations
- method determinations and validations
- specifications (component, in-process, and finished product)
- testing (component, in-process, and finished product)
- chain of custody assessments
- computer system development and validation (including laboratory information systems and data collection and storage systems)