Pharmaceutical competencies

Expertises pharmaceutiques
  • International CMC Development strategies for new products and LCM
  • Due Diligence (Merger & Acquisition, in-licensing, BD technical assessment)
  • CMC development of innovative forms up to scale-up
  • Competitive Intelligence – IP technical strategy
  • GMP Quality Assurance – Inspection Mock-up (EU-FDA-ANVISA)
  • Module 3 eCTD dossiers EU-US-Japan-RoW
  • Industrial scale-up & industrial transfers (CMOs identification & assessment)
  • Implementation of new manufacturing processes or equipments
  • R&D organisation integration
  • Multicultural R&D management practices

Tailor-made services

  • In-licensing of new drug delivery technologies and/or products (in development or mature)
  • Strategic scenarios for international development of an existing product
  • R&D – Quality (GMP) organisation redeployment
  • ANSM – FDA – ANVISA inspection rehearsal /mock-up
  • On site training (CMC Quality – Pharmaceutical Development, Pharmaceutical regulations,…)

Our customers

  • Post integration « Big Pharma » Business Units
  • Franch + European Biotechs
  • BD consulting firms
  • Small/medium size pharmaceutical companies with international expansion
  • Pharmaceutical training centres

A couple of our recent missions

  • « Big Pharma » LCM development projects (post-integration)
  • Due Diligence on women’s health products
  • Plan for deployment of a new « Exploitant » Quality organisation (France)
  • RoW expansion of a European commercial franchise