Regulatory Affairs

A sustained regulatory awareness together with expert consulting ensures our real-time response to any change in the regulatory environment, assuring regular dossier updates.

The Regulatory Affairs team is responsible for writing, compiling, submitting in English language and CTD format, the Marketing Authorisation dossiers under Bluepharma's name, or our partners' following the most suitable procedure, either it is DCP, MRP or National.

Dossier compilation, together with the follow-up of registrations is assured by our team of experienced pharmacists covering EMA, as well FDA regulatory compliance, enabling us to match our clients' expectations with the regulatory authority requirements.