Product Development
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
EU Registration Strategy
CTD Writing
Management of Registration procedure
Product information and Labelling
Early Access to Market
EAP Application Writing
Management of EAP Authorisation procedures
Exploitant services for France
Management of EAP programmes 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
Launch readiness & strategy
Medical Devices
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
CE Marking Strategy & European market entry
Specialised services
SME representation or SME registration support
Quality Management System (QMS), SOP Development & Audit (GMP, GDP, ISO 13485, ISO 22716)
Looking to establish and bring your 1st
life-changing medicine across Europe?
