European Registation Procedures
EPMC helps its clients to determine the most appropriate filing strategy, and manage the relationship with European regulatory authorities.
Orphan Drug Application: we advise you on how to apply for this privileged status for your medicines prior to any Marketing Authorization Application. Success in the Orphan drug application can offer you a higher level of market protection and potential for preferential rates of reimbursement.
Marketing Authorization Application: we help you to receive approval to market your medicine throughout the European Union.
Specialities:
Filing strategy in the European Union (National, Mutual Recognition, Decentralised, Centralised and Abridged applications)
Preparing and organising European Regulatory Procedures:
Scientific Advice
Orphan Drug Designation
Pre-submission agency meetings
Marketing Authorisation Procedures
Centralised Procedure
Decentralised and Mutual Recognition Procedures
Dossier submission (translation services if required)
Response to agency questions (progress through final approval)
