Topical generics: formulation development and equivalence for complex products.
Developing semi-solid formulations requires deep expertise in composition, microstructure, and performance. MedPharm supports straight and value-added approaches with formulation, scale-up, and in vitro testing aligned with FDA and EMA.
Process development helps MedPharm identify manufacturing risk early and control it before scale-up.
Our teams evaluate how critical process parameters (CPPs) and critical material attributes (CMAs) affect critical quality attributes (CQAs) and product performance.
Early risk identification reduces delays, limits material waste, and prevents downstream manufacturing issues.
MedPharm applies a Quality by Design (QbD) and risk-based approach. When appropriate, our scientists use Design of Experiments (DoE) to define design space and identify failure limits.
MedPharm’s research biology and tissue culture capabilities support the development of advanced biological models to evaluate drug performance. Formulation performance testing systems can confirm whether a drug reaches its intended site. However, they cannot determine whether the drug performs its biological function once it arrives. Biological model systems address this gap.
MedPharm provides cosmetic testing services through its Center for Skin Biology (CSB), supporting cosmetic and Over the Counter (OTC) product development with scientifically robust, performance-based data.
With more than 25 years of skin biology expertise, CSB is an end-to-end partner for delivering claims that stand up to both scientific scrutiny and consumer expectations.
CSB combines formulation optimization, product characterization, benchmarking, and custom preclinical models built on proprietary test systems. Our industry-leading skin viability platform maintains biologically active skin for up to 30 days, enabling advanced evaluation of long-term cosmetic, dermatological, and OTC product effects.
MedPharm supplies GMP clinical trial material and ICH stability support for topical drug products across global development programs. We manufacture non-sterile semi-solid and liquid formulations for clinical trials, supporting Phase I–II studies in the UK and Phase I–III in the US, with Phase III capability for select UK programs (including orphan indications), all supported by integrated quality and regulatory systems.
