At MedPharm, we specialize in supporting generic drug developers seeking to bring high-quality, cost-effective alternatives to market—particularly in the topical and transdermal space, where formulation complexity, bioequivalence demonstration, and regulatory nuance demand specialized expertise.
From Q1/Q2 formulation matching to in-vitro bioequivalence testing and ANDA submission support, MedPharm delivers the services, infrastructure, and insight required to de-risk development, accelerate timelines, and meet global regulatory expectations.
Unlike generalist CDMOs, we are deeply immersed in semisolid and transdermal formulations—making us the ideal partner for generic dermatology and mucosal drug products.
We support both traditional ANDAs and 505(b)(2) hybrid submissions for differentiated generics and reformulations.
Our services and study designs are built in accordance with FDA, EMA, and MHRA guidance, including product-specific guidances (PSGs) and IVRT/IVPT requirements.
We specialize in alternative BE approaches using validated In Vitro Release Testing (IVRT) and In Vitro Permeation Testing (IVPT) to reduce the need for full clinical equivalence studies.
MedPharm has supported numerous successful global generic approvals, including corticosteroids, antifungals, antivirals, local anesthetics, and combination products.
We provide comprehensive support for generic development, from early feasibility through submission and approval.
In the fast-moving world of generics, success depends on scientific rigor, efficient execution, and total regulatory clarity. MedPharm delivers all three—bringing your product to market faster, with fewer surprises and stronger support at every stage.