Marketing Authorization Holders

Our advisory regulatory service can provide you with help in establishing a strategy for registration in Europe

We are specialized in advisory on EMEA affairs and strategic product development, combining European and US clinical trial performance
Preparation, review and submission of Marketing Authorization applications in Europe
Product licence maintenance (MRPs, variations and renewal)
Regulatory services for other products as medical devices, diagnostics, cosmetics and nutrients

Regulatory and Scientific Affairs

Legal interface with the agencies on behalf of clients
Advise on local requirements for national applications
Decentralised and centralised applications
Representation for US and Israeli manufacturers
Consultancy in preparation and appliance for MA according to EMEA guidance
Import and customs clearance documents

Pharmacovigilance for marketed and pipeline products

Translate and forward SAEs to clients within 1 working day
Forward communication to/from agency
Forward SUSARs and PSURs to the agencies
Inform clients of local changes