At MedPharm, we develop and manufacture drug products in alignment with leading regulatory authorities, including the FDA, EMA, MHRA, and other global health agencies. From early-stage planning to submission and post-approval support, we ensure every formulation, process, and dataset is built for regulatory success.
ICH
ICH Guidelines (Q1–Q10)
Stability, quality risk management, pharmaceutical development, and GMP principles
FDA
FDA 21 CFR Parts 210/211, 312, 314
U.S. regulatory framework for drug product development, manufacturing, and submission
EU / UK
EMA & MHRA Compliance
GMP alignment for clinical and commercial products in Europe and the UK, aligned with EMA guidance and supporting hybrid pathways, including but not limited to:
Global
WHO and TGA Considerations
Support for multinational projects requiring cross-jurisdictional documentation and testing
PSG
Product-Specific Guidance (PSG)
Expertise in navigating topical and transdermal PSGs for complex ANDA pathways
GMP and GLP Compliance
Operations supporting development and manufacturing activities
Manufacturer’s Authorisation (MIA) for IMP
Authorized for the manufacture of Investigational Medicinal Products (IMP) at our UK site, including Qualified Person (QP) certification and release for clinical trial supply
Controlled Drugs Licenses
Enabling work with regulated substances
FDA Inspection (Durham, NC)
No Action Indicated (NAI) classification with no Form 483 observations
We apply current regulatory expectations directly to your program, helping reduce risk, avoid delays, and support a smoother path to approval.
