Our Pharmaceutical services
Comprehensive pharmaceutical services: product development, regulatory strategy, compliance, and commercialization for rapid market access in Europe.
Our Pharmaceutical services
Product Development
- Drug Development Consulting
- Regulatory strategy & Roadmap
- Health Authority meetings
- EMA or EMA/HTA Scientific Advice
- Chemistry, Manufacturing and Controls (CMC) solutions
- Orphan Drug Designation (ODD)
- Paediatric Investigation Plan (PIP)
- IB and IMPD writing
- ASMF, DMF and CEP writing
- Advanced Therapy (ATMP)
- Gap analysis/Due diligence
- PRIME (priority medicines) scheme
Registration
- Drug Registration
- EU Registration Strategy
- CTD Writing
- Management of Registration procedure
- Product information and Labelling
Early Access to Market
- EAP Application Writing
- Management of EAP Authorization procedures
- Exploitant services for France
- Management of EAP programs in Europe
Commercialization
- Variations, renewals and MA transfer
- Promotional material review & Sign Off
- Compliance with Healthcare Professionals
- Quality System and Audit
- Exploitant status for France
- Drugs Launch Excellence
Other Expertises
Medical Devices
- Medical Devices Launch Excellence
- CE Marking Strategy & European market entry
- Development – Regulatory positioning & product development support
- Regulatory & Registration – Technical documentation (MDR 2017/745) & CE marking
- Post-Market Compliance – Documentation updates, Change management & Promotional material compliance
Specialized services
- SME Status & Exploitant Services
- Quality Management System (QMS), SOP Development & Audit (GMP, GDP, ISO 13485, ISO 22716)