DRUG REGULATORY AFFAIRS
Preparation of documentation for MA (complete applications, variations, renewals, …) in eCTD through national, mutual recognition, centralised or decentralised procedure.
Writing of clinical, non-clinical and quality overviews, safety updates…
Package leaflet. Readibility tests.
Evaluation of registration dossiers.
Legal advice.
Our deep knowledge of EU regulations coupled with a large experience within european agencies allow us to cut through red tape and obtain marketing authorisations quickly and efficciently.
We have an excellent reputation among Regulatory Authorities for the quality of the dossiers, the technical preparation of our staff and our reliability.
We can take over all the obligations inherent to the Holder of Authorisation in its place.
ELM - drug regulatory affairs  
ELM - drug regulatory affairs
ELM Farmacéutica , C/ Provenza 326, Eº 1ª, Barcelona 08037 Spain
Tel: +00 34 934591032 / 609037890 - Fax: +00 34 932156030 - info@elmpharm.com