Our regulatory staff's tireless efforts to prepare our first Marketing Authorisation Application (MAA) were rewarded this month by the acknowledgement of its timely and successful validation. RPI now has full capability to directly submit all eCTD submissions related to the authorisation and maintenance of medicinal products in Europe via EMA’s eSubmission Gateway. The use of the Gateway has significantly improved the EMA’s efficiency in handling the receipt of submissions, making them quickly available within the European Review System.
Find out more about how RPI can support your EMA submissions.