Regulatory Affairs

The Regulatory Affairs Department has extensive experience in the registration of pharmaceutical products in Greece and abroad. It has successfully obtained Marketing Authorizations for help pharmaceuticals and third parties in more than 20 countries in a variety of geographical regions and has expertise in the development of dossiers according to country specific requirements.

The department offers the below services to help pharmaceuticals and partners:

1. Development, update and conversion of drug product dossiers in EU-CTD or at the specific format as per the selected country requirements
2. Registration of drug products, medical devices, cosmetics and food supplements to Health Authorities
3. Management of licenses post-authorization
4. Monitoring of regulatory requirements
5. Interaction with Health Authorities and third parties