Pharmaceuticals

Before a registered product can be marketed, data demonstrating the product safety and effectiveness must be presented to the Regulatory Authorities for review. This review is oriented to grant the public health and safety, and its outcome is the issue of the Marketing Authorization.

Do you need a partner that lead you in products Registration Dossier draft issue?

Do you need a partner that support you in the review/variation of products Registration Dossier?

Do you need to implement the new CTD format (Common Technical Document) for the Dossier submission in accordance with new European/International directives and in accordance with the ICH M4?

Thanks to the experience reached in the national/international area, affariregolatori set itself as a partner for the setting of the registration dossiers and the simplification/handling of the regulatory activities of your company, by offering:

Advices on national/international regulatory guidelines
Draft of CTD
Preliminary examination and draft of the documentation for first registration, variations and renewals before submission to AIFA or to the competent Ministry of Health as Common Technical Document (CTD)
Handling/Simplification of regulatory activities