How EMA and FDA approvals help in getting SFDA approval in an accelerated assessment procedure. Learn more about what is called Abridged and verification registration.
An overview on the regulatory strategy development process for the Saudi market. The analysis methods, elements to consider, documentation, and the series of recommended stages.
Detailed description of the SFDA drug registration requirements in Saudi Arabia. The related guidelines and regulations for different types of new and generic drug applications in SFDA. Including file structure and how to submit it in eCTD.