Product lifecycle management
Obtaining a Marketing Authorisation (MA) is not the end but the beginning of your journey with Competent Authorisation. There are many duties and responsibilities placed upon the Marketing Authorisation Holder regarding maintenance of MA, e.g. timely payment of annual fees, updating the dossier in line with technological progress, application for safety variations and others. Moreover, as time passes, some post-authorisation activities should be carried out, although they are not obligatory, they do increase the attractiveness of the product.
SciencePharma offers wide range of product lifecycle managements services keeping your MA and dossier always up-to-date and attractive:
- all types variations management (type IA and IAin, type IB, type II variations and notifications)
- line extensions applications
- sunset clause exemptions applications
- annual fees
- renewals
- withdrawals.