Product development : Supporting the development of the best product while ensuring quality compliance
Strategic consultancy during global pharmaceutical development and lifecycle management
Expertise in all types of API (chemical, biological, herbals) – Development of ASMF, DMF, CEP – Development of USP/EP monographs
Drug product development :
Formulation (development, patentability), process (scale-up, validation, manufacturing strategy)
Analytical development (development, validations and transfer, gap analysis, specifications)
Stability studies (design, trend analysis, setting of shelf life)
Project management : coordination of all activities in pharmaceutical development from API selection, product development, clinical supplies, transfer to CMO, to registration and geographical roll out, including CMOs and CROs management
Decision making to drive investments: Due diligence, gap analysis and experts reviews
Composed of proven experts from the pharmaceutical industry, our team is ready to answer to your needs in any area of product development, commercialisation and early access programs, and life cycle management
