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

• Outsourcing / Contract negotiation with CDMOs; manage and overview all CMC development activities
• Performing Technical Due Diligence of Manufacturing Facilities / Biopharmaceutical Projects
• Reviewing CMC sections of regulatory documents such as IMPDs, INDs and Comparability Reports
• Supporting meetings and interactions with Regulatory Authorities