Lifecycle Management Services

A Marketing Authorization Holder (MAH) is responsible for keeping the registered dossier up to date as per country-specific requirements for a products’ lifecycle management. Based on the concerned Health Authority requirements, the MAH should file an Annual Report (AR) or a Renewal Request on a periodical basis. For  annual reports or renewals, Health Authorities worldwide have a different set of requirements for filing the submissions. In such scenarios, to get the approval/acceptance at the earliest, a Regulatory submission strategy plays a significant role. Hence, manufacturers may wish to consider a specialized Regulatory consulting for CMC Lifecycle Management of the Regulatory Submissions for already approved products.