300+No of Products
22No of Countries
Regulatory Affairs is a highly competent team with strategic and tactical experience that manages the modern regulatory landscape by following regulatory practice, monitoring changing legislations and designing appropriate regulatory strategy and guidance for development and manufacture of products.It specialises in understanding the path ways and requirements of various regulatory authorities to work in collaboration with respective departments to generate first-time documentation for faster approvals and early launch of the products to create opportunities in a regulated environment.
More than 400 dossiers of quality, safety and efficacy are filed in both regional and CTD formats for different category of products in semi-regulated and emerging markets across the globe. More than 300 approvals received and working in tandem with Health Ministries ensure product life-cycle management and post-marketing surveillance. Regulatory Affairs ensures facilitation for cGMP, GCP and ISO regulatory inspections by various regulatory authorities and further maintenance of the approvals.