Regulatory Affairs

Obtain and maintaining Marketing Authorizations: National and European

PharmaRegistrations has a substantial track record in registering - European and National - new applications and variations for large multinationals and smaller companies. We master both the regulatory and scientific know-how. Together with our management minded focus we deliver reliable and transparent services, with shorter lead-times.

We take care of the whole approval process, including:
· Time-saving and feasible planning
· Redaction of the dossiers, including expert reports
· Follow-up at the Competent Authorities
· Launch preparation
· Product maintenance: updates, variations, pan-europeanization


Our consistent professional approach resulted in excellent contacts with the competent authorities and opinion-leaders. Therefore we can efficiently steer your dossiers to quick approval.