Applications

Applications

Our experience is your advantage.


PRSG's regulatory affairs specialists will be at your site and guide you through the complex regulatory world. Our team assists you with the planning and performance of your application for marketing authorisation as well as with any necessary and arising post-approval activity.

 

Initial applications for marketing authorisations
   - Full application
   - Generic / Hybrid application
   - Informed consent application
   - Bibliographical application
   - Traditional registration

Variations

Renewals

Follow-up-activities

Updating of marketing authorisation documentation

Preparation of electronic submission dossiers

Processing deficiency letters - Communication with
     regulatory authorities

Preparation of pharmacological and toxicological expert reports, clinical expert reports, environmental compatibility testing, etc.

Monitoring of deadlines

 

 

Make use of our experience in the area of preparation and submission of documentation for

National Procedures (NP),

Decentralised Procedures (DCP),

Mutual Recognition Procedures (MRP) and

Centralised Procedures (CP).