EUROPEAN BASED DRUG DEVELOPMENT CONSULTANCY

INNOVATIVE DRUG DEVELOPMENT AND REGULATORY STRATEGIES

DEVELOPMENT PHASE

Scientific advice
Paediatric Investigation Plan
Clinical Trial Application
Orphan Drug Designation

APPROVAL PHASE

Centralised procedure
Decentralised Procedure
Mutual Recognition Procedure
Oral hearing

POST-APPROVAL PHASE

Post approval commitments
Variations
New indications
Pricing and Reimbursement dossier
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