Identification, management and coordination of suppliers and service providers

• Suppliers: active ingredients, excipients, packagings
• Operational subcontractors:
  – formulation, analytical, industrial (CMO, CDMO)
  – non-clinical (in vitro and ex vivo models,
   biowaiver)
  – pharmaco-toxicological
  – clinical (CRO)

Implementation of the pharmaceutical development strategy

• Steering of development stages:
  – formulation: pre-formulation, formulation
  – analytics: development and validation
  – industrialisation: scale-up, optimisation and
   process transfer
  – stability studies: preliminary, ICH
  – non-clinical and clinical studies: in vitro, ex vivo,
    bioequivalence study, phase I, II and III studies
• Optimisation of the timelines throughout the duration of the project

Communication with the subcontractors

• Technical communication with subcontractors
• Review, comments and follow-up of the deliverables
• Weekly conference calls, on-site meetings
• Minutes of phone calls and physical meetings

Writing of Module 3

Company agreed by French Ministry of Research (CIR -CII)