Our Case studies

A highlight of our key representative cases

• Project #1: Established solutions to ensure a reliable and efficient supply chain for the company's products in registered markets

• Project #2: Identified and implemented solutions to ensure reliable and efficient process development operations aligned with product launch targets

• Project #3: Support in FDA readiness program – deviation management (investigation & writing)

• Project #4: Lead implementation of electronic batch production record (eBPR) into the company’s QMS

• Project #5: Enhance CMC strategy for Phase III clinical trial entry, L&E risk assessments

• Project #6: Project management for TT and CMC strategy support for commercial manufacturing and scale-up

• Project #7: Conceptual & basic design of mammalian DS manufacturing facility & laboratories

• Project #8: Conceptual & basic design of viral manufacturing facility & laboratories