Consulting

MedSites offers regulatory affairs support at every stage—both prior to the submission of a marketing authorization dossier and throughout the registration process. Our team assists in formulating effective responses to health authority (HA) inquiries and leverages extensive hands-on experience to interpret complex regulatory scenarios. Engaging with regulators during the pre-submission phase can be critical, and we help clients seek early scientific advice to ensure alignment with regulatory expectations. By guiding your interactions with health authorities, we help you build consensus during pre-submission meetings. If you require regulatory advice specific to Egypt, MedSites is here to support you.