Application dossier and EU regulation

Evaluation of EU registration policy according to your needs.

Experience in national, mutual recognition, centralised or decentralised procedures.

Preparation of documentation for MA (complete applications, variations, renewals…) in eCTD.

Writing of clinical, non-clinical and quality overviews, safety updates…

Evaluation of registration dossiers.

Tracking and discussion with European regulatory agencies.

Legal advice.

EU TRANSFERS

Distributors, Manufacturers, Responsible for release

Supplying of partners within EU (distributors, manufacturers and / or responsible for release).

Licensing

Because of our long experience in the pharmaceutical industry we have the contacts and the know-how to act efficiently as a catalyst between companies.

Strategy and tracking until EU MKT authorisation


Evaluation of EU registration policy according to your needs.


Facilitation of all legal and fiduciary matters within EU.

Development

We have agreements with development companies and institutions to develop generic or new pharmaceutical forms of medicinal products:

-	Pharmaceutic studies: stability, dissolution, finished product specifications, biobatch production.
-	Bioequivalence studies.

Pharmacovigilance in EU

We can take over pharmacovigilance responsibility assuming and performing all related activities in close agreement with MAH.

Pharmacovigilance activities include but are not limited to receipt, recording, collecting of ICSRs, literature review, medical review of safety data, signal detection and risk management, preparation and submission of expedited reports, preparation and submission of PSURs, electronic ICSRs ...