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.


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)