300+No of Products
22No of Countries
Our Regulatory Affairs team is highly competent with strategic and tactical experience that manages the modern regulatory landscape by following Good Regulatory Practices (GRP), monitoring changing regulations and designing appropiate regulatory strategy for the product development.
Regulatory Affairs team works in collaboration with respective departments to generate Right First Time (RFT) documentation for faster approvals & early launch of the products.
Till date, more than 500 dossiers have been filed in CTD & regional formats for different category of the products in semi-regulated & emerging markets across the globe, out of which more than 300 approvals are recieved. The team ensures the lifecycle management of these registered products & their post marekting sureveliance. It also works in tandem with the various Health ministries to faciliate the regulatory inspections of our sites prior to product registration & their maitenance.
In a nutshell, they act as a communication channel & chief negotiators with Health ministries during various stages of product registration.