Our Pharmaceutical services

Group 470 Product Development

Health Authority meetings

Chemistry, Manufacturing and Controls (CMC) solutions

IB and IMPD writing

ASMF, DMF and CEP writing

Advanced Therapy (ATMP)

Gap analysis/Due diligence

PRIME (priority medicines) scheme

Group 470 (1) Registration

CTD Writing

Management of Registration procedure

Product information and Labelling

Group 470 (2)Early Access to Market

EAP Application Writing

Management of EAP Authorization procedures

Management of EAP programs in Europe

Group 470 (3)Commercialization

Promotional material review & Sign Off

Compliance with Healthcare Professionals

Quality System and Audit

Exploitant status for France

Other Expertises

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Medical Devices

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
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Specialized services

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