Sophena
Sophena - Your partner in regulatory affairs since 2010
As a service provider we take over all tasks connected to regulatory affairs for medicinal products.
Submission of new applications for DCPs, MRPs or national procedures in all EU-countries and Switzerland
- Preparation of registration dossiers
- Submission of the applications
- Procedure management
- National phase
Maintenance of existing marketing authorisations
- Variations
- Renewals
- Digitalisation/conversion of dossiers
- Preparation of eCTDs
We are gladly at your disposal to answer any questions that you may have concerning our offers and services. Simply contact us by phone (+49 8221 9160331) or by email (regulatory@sophena.eu).