Complete CMC and quality oversight responsibility for a very small biotech startup company, with no internal technical operations capability or experience

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 ā€˜Sā€™ and…

Continue Reading Complete CMC and quality oversight responsibility for a very small biotech startup company, with no internal technical operations capability or experience

CMC expert support to an innovative drug development program (drug substance and drug product) for a mid-sized established traditional pharmaceutical group

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…

Continue Reading CMC expert support to an innovative drug development program (drug substance and drug product) for a mid-sized established traditional pharmaceutical group

Technical expert support for the transfer of a portfolio of mature injectable products from one CMO (liquid in vials) to another CMO (solution in pre-filled syringes)

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…

Continue Reading Technical expert support for the transfer of a portfolio of mature injectable products from one CMO (liquid in vials) to another CMO (solution in pre-filled syringes)