The Regulatory Operations Team consists of experienced specialists dedicated to managing all aspects of regulatory submissions. By combining operational, scientific, and strategic expertise, we ensure successful execution of regulatory submissions thereby supporting our client’s business goals. We are experienced in regulatory submissions in EU and US including submissions for new Marketing Authorisations as well as Life Cycle Management submissions.
The RO Team:
- Provides guidance and regulatory strategies
- Provides regulatory project management
- Conducts pre-submission meetings with Health Authorities
- Prepares, formats, compiles, and submits all types of regulatory documents and dossiers in EU, US, CH, and CA.
- Manages all steps involved in all types of US applications and EU marketing authorisation procedures – MRPs DCPs, CPs – including the response phase and the national phase following completion of the procedure.
- Manages all steps involved in Life Cycle Management procedures, incl. renewals, variations, MA transfers and de-registrations.
For more information about the Regulatory Operations team and the services we provide, please contact Sanne Elitha Svendsen, Head Regulatory Operations.