Pharmaceutical development

Pharmaceutical development strategy and 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
Identification, management and coordination of suppliers and service providers
  • Suppliers: active ingredients, excipients, packaging
  • Operational subcontractors:
    • formulation, analytical, industrial (CMO, CDMO)
    • non-clinical (in vitro and ex vivo models, biowaiver)
    • pharmaco-toxicological
    • clinical (CRO)
Module 3 development and writing Communication with subcontractors and customers
  • Weekly conference calls, on-site meetings
  • Review, comments and follow-up of the deliverables for all operational service providers
With our Partner