Regulatory Standards
Global Alignment. Local Expertise. Proven Success.
At MedPharm, we develop and manufacture drug products with full alignment to the world’s leading regulatory authorities, including the FDA, EMA, MHRA, and other global health agencies. From early-stage planning to final submission and post-approval support, we ensure that every formulation, process, and document meets the standards necessary for approval—wherever you’re going to market.
Our Regulatory Foundations:
ICH Guidelines (Q1–Q10)
Stability, quality risk management, pharmaceutical development, and GMP principles
FDA 21 CFR Parts 210/211, 312, 314
U.S. regulatory framework for drug product development, manufacturing, and submission
EMA & MHRA Compliance
GMP alignment for clinical and commercial products targeting Europe and the UK
WHO and TGA Considerations
Support for multinational projects requiring cross-jurisdictional documentation and testing
Product-Specific Guidance (PSG)
Expertise in navigating topical and transdermal PSGs for complex ANDA and hybrid pathways
We stay ahead of evolving regulatory expectations and apply those insights directly to your development strategy, helping you anticipate challenges and reduce approval timelines.
