Objectives:

Regulatory Affairs is the crucial link between the company , our products and the Saudi Food & Drug Authority (SFDA). The department plays a key role in maintaining the legal compliance of our products with SFDA regulations. Keeping abreast of international legislation, guidelines and customer practices in all countries that the company is exporting to.

Functions:

1. Preparing the CTD files of our registered products for export.

2. Preparing the CTD & NeeS files for Marketing Authorization Renewals.

3. Preparing the CTD & NeeS files for Marketing Authorization Variations.

4. Preparing the requirements of company registration in other countries for Export.

5. Preparing the eCTD files for registration of the new products in the pipe line.

6. Preparing the requirements for Toll Manufacturing approvals with other Multinational companies.