MedPharm manufactures clinical trial material to meet global regulatory requirements.
Our teams support compounding, filling, packaging, and labeling for all non-sterile topical formulation types, including liquid formulations (pump and pressurized sprays) and semi-solids.
Stability-indicating methods are established early and validated for full-scale batch testing. All stability data is provided in IMPD, IND, or CTD format to support regulatory submissions. Stability testing is available across all ICH zones, with ICH stability chambers operational at MedPharm’s US site.
Strategic Advantages
MedPharm’s GMP experts bring extensive combined experience across development and manufacturing. Subject Matter Experts support regulatory meetings, information requests, deficiency letters, and scientific justifications.
MedPharm operates purpose-built laboratories in the UK (3,500 sq ft) and US (11,000 sq ft). All instruments and equipment are fully qualified and calibrated, with SOPs defining use, maintenance, and calibration.
GMP manufacturing follows MedPharm’s Quality Management System, compliant with EudraLex Volume 4 (GMP) and ICH Q10.
Systems include:
Established in 1999, MedPharm is an internationally recognized pharmaceutical development company with over 25 years of expertise in topical and transdermal drug development.
