REGULATORY AND MARKET ACCESS
The close regulatory collaboration with our partners at each step of the specific regulatory process.
The close regulatory collaboration with our partners at each step of the specific regulatory process and the deep regional regulatory knowledge provide a reliable market access strategy ensuring the timely launch of these substantial molecules in the MEA region countries. Cevomed regulatory team experience and trust-based relationships with national and regional regulatory authorities and partners help to support all aspects of regulatory affairs for our products. Our far-reaching experience and integration allows us to monitor proactively for potential risks and challenges. We anticipate and address queries raised by local regulatory authorities in advance to facilitate the efficient review of applications, maximizing the probability of a successful and speedy outcome. As a part of our regulatory services, we evaluate information to ensure that it is complete and of suitable quality to be submitted to the Health authorities, prepare the requirements for submissions based on Authorities requirements. We submit and follow-up the Registration files until granting the Marketing Authorization approval, we are also assisting with post Marketing Authorization procedures (Renewals and variations).