Research & Development

CMC and Regulatory Affairs:

Enzene has a strict commitment towards developing and delivering quality affordable products to meet the domestic and international requirements. CMC and Regulatory affairs team ensures the development and delivery of quality products by streamlining SOPs, step by step review for compliance and regular internal audits. Enzene's CMC-RA quality initiative covers two key functional areas:

  • Quality Assurance
  • Regulatory affairs

Quality Assurance is responsible for continuous monitoring of key data, timely documentation of reports and ensures strict compliance to the quality management systems. The Quality Assurance team also ensures proper qualifications of the instruments in our state-of-the-art facilities. We monitor and maintain strict quality of our products, processes and services, on a consistent basis to meet global quality standards. Regulatory Affairs (RA) team interacts closely with the domestic and international regulatory bodies like DCG (I), EMA, USFDA, etc. and guides product development to meet domestic and international regulatory requirements. RA team is also responsible for preparing dossiers to support various stages of CTD filings from preclinical studies to MAA. Strategic planning by CMC-RA team ensures that Enzene's global vision of making world class products at an affordable price is fulfilled.