FROM DEVELOPMENT TO MARKETING
Drug Development
EU Dossier for MKT Authorisation
MKT Authorisation in EU
COMMERCIALISATION
in EU
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.
ELM Farmacéutica , C/ Provenza 326, Eº 1ª, Barcelona 08037 Spain
Tel: +00 34 934591032 / 609037890 - Fax: +00 34 932156030 - info@elmpharm.com