Regulatory Affairs

In today's competitive environment the reduction of time taken to reach the market is critical to a product's and hence the company's success.

Our Regulatory Affairs team keeps track of the ever-changing legislation in all the regions in which the company intends to market its products.

'Right First Time' approach of our Regulatory Affairs plays a crucial role in coordinating scientific endeavor with regulatory demands throughout the life of the product, helping to maximize the cost-effective use of the company's resources. It also advises on the legal and scientific restraints and requirements, collect and evaluate the scientific data generated by R&D.

Our Regulatory Affairs is capable of all types of regulatory submissions (Dossiers / ANDA / ANDS / CTD / e CTD) to any of the semi-regulated to highly regulated markets ensuring fast turnaround in business.