TABUK’s regulatory affairs department provides advice on the legal and scientific restraints and requirements, collects, collates and evaluates scientific data, submits registration documents (dossiers) to regulatory agencies, and carries out all the subsequent negotiations necessary to obtain and maintain marketing authorizations for all the products concerned.
As a way to fulfill its commitments, TABUK's regulatory affairs  department makes sure that the product information submitted to the authorities is as complete as possible and in the correct form. They are also responsible for subsequent contacts with the regulatory authorities. Since authorizations are issued for a specified time, and have to be renewed before expiry, a very important part of the regulatory affairs function consists of the maintenance and updating of existing authorizations, and in handling the inevitable variations that emerge from time to time.

TABUK’s Regulatory Affairs Department can offer:

	Expert opinions on technical and legal matters associated with the registration of products in all our markets
	State of the art dossiers as per the latest European standards (CTD-Format), submitted to authorities within the European Union .
	A number of ANDAs for the US Market. ANDA (US CTD).
	Efficient evaluation of technical information, including Drug Master Files, patent issues, clinical trials and bioequivalence data