We have in-depth expertise and knowledge of the highly complex BioTech / Pharma manufacturing and distribution space.
We have extensive sourcing experience and expertise in the sourcing of CDMO, CMO and CROs in EU, USA, China and India.
Low cost and compliant manufacturing
Expertise in all aspects of cGMP production for example; cell banking, cell culture, fermentation, formulation, fill-finish and lyophilisation processes.
Site and process validation, quality audit and quality agreement.
EU and US EP / USP, 21 CFR part 211.
cGMP and GDP supply chain and logistics. Storage and cold chain (GDP) chain of custody.
Cold chain process and equipment validation.