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, provide laboratory compliance consulting that helps make the FDA regulatory and compliance process smoother for laboratories. We deliver practical lab compliance solutions designed to improve documentation, consistency, and inspection readiness.
Laboratory Compliance Services
Our FDA consulting services and FDA training for labs include:
- Laboratory GMP and GLP audits
- Part 58 audits for non-clinical laboratories, conducted under the 21 CFR Part 58 GLP regulations
- Contract analyses
- Lab SOPs (Standard Operating Procedures)
- Lab equipment validations and calibrations
- Method determinations and validations
- Specifications for component, in-process materials, and finished product
- Testing for component, in-process materials, and finished product
- Chain of custody assessments
- Computer system development and validation, including laboratory information systems and data collection and storage systems
FDA Support for Laboratories
FDA Compliance Group helps laboratories prepare for GLP inspections, which the FDA conducts under its GLP inspection program for nonclinical studies. We help laboratories strengthen the systems that support quality, accuracy, and compliance. Whether you need a lab compliance consultant for validation, testing, documentation, or computer systems, our team provides support that is practical and aligned with FDA expectations.
For more information on our FDA consulting services for laboratories or to schedule a consultation, please contact us.