Some Recent Case Studies (12 months)

Case Study 1

Working with a European virtual pharmaceutical company in managing the outsourced API manufacturing campaign in support of Phase III clinical development, by integration of Quality-by-Design (QBD) principles. Currently manufacturing API for registration batch manufacture (drug product).

Case Study 2
Provided technical due diligence support for a UK-based client ahead of in-licensing several new small molecule assets. This included a written assessment of the quality of the CMC package, including gap analysis and identification of CMC risks for clinical development.

Case Study 3
Working with a UK University who has a Phase I asset. Successfully delivered GMP API and currently managing the drug product CMO and drafting the IMPD in support of the Phase I regulatory submission

Case Study 4
Working with several UK virtual start-up companies with small-molecule assets, managing the development and GMP production activities at the selected CMOs in support of Phase I supply. Includes route scouting and solid state activities.