Our Pharmaceutical services

Drug Development Consulting

Health Authority meetings

Chemistry, Manufacturing and Controls (CMC) solutions

Orphan Drug Designation (ODD)

IB and IMPD writing

ASMF, DMF and CEP writing

Advanced Therapy (ATMP)

Gap analysis/Due diligence

PRIME (priority medicines) scheme

Drug Registration

EU Registration Strategy

CTD Writing

Management of Registration procedure

Product information and Labelling

EAP Application Writing

Management of EAP Authorisation procedures

Exploitant services for France

Management of EAP programmes in Europe

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

Launch excellence