Pharmaceutical competencies
- 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
- CDMOs /CMC CROs
- 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
