Objective Provide a detailed business case for the operational capability (including estimated profitability) of a contract manufacturing organization on behalf of a pharmaceutical group looking for a strategic acquisition Outcome…
Objective Provide scientific and industrial rationale for the innovative character of the patent claims challenged by a potential generic competitor Outcome Writing of several expert statements Witness in front of…
Objective Manage the complete network of external service providers for drug substance and drug product process development and manufacturing as well as analytical services; drafting of all CTD ‘S’ and…
Objective Provide scientific, manufacturing and compliance support to the pharmaceutical development group of a traditional mid-sized pharmaceutical company developing an innovative complex synthetic molecule formulated as a parenteral drug Outcome…
Objective Provide technical and compliance support on-site during critical steps of the pre-PPQ and PPQ runs of a complex and highly innovative synthetic active pharmaceutical ingredient Outcome Successful integration with…
Objective Prepare and handle the FDA inspection of a fine chemicals manufacturing site, where one of the site legacy products had been the object of a ANDA submission in the…
Objective Act as interim head of a fully integrated PDS unit within the premises of a leading European sterile manufacturing CMO Outcome P&L level management of the PDS Department Successful…
Objective Due to the discontinuation of the related range of activities by the historical CMO, transfer of a portfolio of injectable emergency medicines to another CMO while transitioning to a…
Objective Creating an in-house GMP-compliant manufacturing capability for a small biotech startup in order to fully leverage the technological platform developed by the firm Outcome Recruitment of a small team…
Objective Selecting and qualifying a primary and secondary manufacturing service provider for the transfer of the in-house developed biotech drug candidate, suitable for supplying clinical-grade batches Outcome Identification and qualification…