Medimo Oy

Marketing authorisations

We manage all marketing authorisation services for human and veterinary drugs for you: we compile applications, maintain marketing authorisations, write product information texts, review secondary and primary packaging material and marketing materials, update regulatory databases, and offer translation assistance.

Regulatory Affairs

If you have any questions related to marketing authorisations for medicines, please contact us. Even in this field, the requirements are always changing, but Medimo remains and keeps itself up to date. Medimo has worked with the following tasks related to marketing authorisations for medicines:

Marketing authorisation applications

Planning of marketing authorisation strategy
Preparation and management of applications
Evaluation of marketing authorisation dossiers
Coordination of MRP, DCP, NP and CP processes

Maintenance of marketing authorisations

Variations
Notifications
Renewals
Rx to OTC switches
MAH transfers

Product information texts (SmPC, PL, labelling)

Writing of Product information text

Translations

Proof-reading of mock-ups

Updating of local compendia texts

We can manage tasks related to marketing authorisations for you throughout the life cycle of a medicinal product or medical device. Contact us – we will provide answers to your questions quickly!