Recently, an US-based client had approached us to provide Regulatory strategy for its antiretroviral (ARV) drug in multiple countries of the African continent. For this project, MakroCare leveraged it’s Reg Intel database (VISTAAR) and regional consultants to arrive at the information needed for sound strategy like (a) Regulatory approval timelines for standard or expedited procedures for its drug, and (b) Labeling requirements for primary and secondary packaging with comparison on physician information, product information for patients and language requirements.
This strategy help client to aim their planning process effectively while introducing their product in the African markets and make sure the regulatory requirements per the NRA of each country is met with. Given the overall objective of prevention of AIDS in Africa, it also gives MakroCare immense satisfaction to be associated with this project and further the social cause.
VISTAAR is MakroCare’s global Regulatory Intelligence (RI) platform that helps global Regulatory (Strategy, Policy, Operations, and Submissions) teams in BioPharma and Medical device companies. It provides updated guidelines/regulations from multiple sources for IRB/clinical submissions, market authorization, safety reporting, manufacturing, LCM and other details.