GST : 27AAXCA7876Q1Z8
4.0/5
Our Services
We offer a complete product range of Lifecycle Management Services and Post Approval Changes Submission 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.
To enhance productivity and to optimise the operational cost, medicinal product manufacturers propose certain changes to the registered content of the medicinal product applications/dossiers. Any change to the registered content of medicinal products should be submitted to the respective Health Authority (HA) in the appropriate submission procedure with supporting data prior to its implementation. Based on the impact of the change, the requirement of prior approval would be determined referring to the CMC post-approval Regulatory affairs submissions (post-approval supplements/amendments/CMC variations) guidelines of the respective HAs. In this phase, the importance of the Regulatory strategy for post-approval Regulatory affairs changes submission is significant.
Miss Gauravi Manoj Jadhav (Avighnakalp Solutions (OPC) Pvt. Ltd.)
Holy Cross Road, Navgaon, West, Dahisar, Mumbai, Maharashtra - 400068, India
Share us via
