• Support on API sourcing (worldwide contact with GMP manufacturers)
  • Elaboration of API development plan according to requirements for Master File technical documentation (defining all necessary data such as batch numbers, batch sizes, characterization tests, API specifications, analytical methods, method validations, stability protocols …)
  • Review of Master File (ASMF, DMF, VMF) on CTD format for Europe and US
  • On site Pre-audit/Pre-inspection for Compliance to Good Manufacturing Practices (cGMP) on API manufacturing facilities (fermentation, synthesis, micronization, sterilization, testing sites)
  • Review of IT infrastructure for Data Integrity Check (IT systems validation, procedures for access levels on computerised systems, training of employees for proper use of IT systems)