Ph.D. Biotechnology

 

Consulting Services are offered within the following areas of Drug Development:

• CMC Development - Drug Substance & Drug Product, including Cell Line Development, Fermentation and Purification Process Development, Scale Up, Formulation Development (liquid, freeze-dried), Drug Product Process Development - Aseptic Filling, Analytical Development, Clinical Supply - cGMP Manufacturing

• Establish integrated CMC Development Plans (CMC, non-Clinical, Clinical, Regulatory)
• Outsource / Contract negotiation with CDMOs; manage and overview all CMC activities
• Perform Technical Due Diligence of Manufacturing Facilities / Biopharmaceutical Projects
• Review CMC sections of regulatory documents such as IMPDs, INDs and Comparability Reports
• Support clients in meetings / interactions with Regulatory Authorities