Audit & Inspection History
Delivering with Confidence Through a Culture of Compliance
At MedPharm, regulatory excellence is integral to our operations. From early-stage development to GMP clinical and commercial manufacturing, our commitment to Good Manufacturing Practice (GMP) ensures that we deliver safe, effective, and high-quality products that meet or exceed global compliance standards.
Our dedicated Regulatory Affairs team collaborates across all functions to uphold the latest international regulatory requirements and proactively prepare for inspections from agencies such as the FDA, EMA, and MHRA. We maintain a strong culture of audit readiness and take pride in our long-standing history of successful inspections at all sites.
Whether you are pursuing IND, NDA, ANDA, or IMPD approval, MedPharm provides regulatory-aligned documentation, robust quality systems, and expert guidance at every phase.
Recent Audit History
- Guildford, UK – [MHRA] (General GMP), 2023
- Durham, NC – [FDA] (Pre-Approval Inspection), 2022
- Stirrup Creek, NC – [FDA] (GMP), 2022
- Guildford, UK – [ISO] (ISO 9001), 2021
- Durham, NC – [NC DHHS] (State GMP Inspection), 2020
- Stirrup Creek, NC – [ANVISA] (Brazil GMP), 2020
Note: This list will be updated regularly to reflect our most recent inspections.
Confidence Built on Compliance
At MedPharm, we view regulatory compliance not as a checkpoint, but as a foundational principle. With extensive experience in regulated markets and a proven track record of inspection success, we ensure that your product journey is founded on quality, integrity, and trust.
