Regulatory Services Our clientele consists of numerous local and international manufacturers, distributors, importers, etc. We assist them by liaisoning on their behalf with all sections of the state and central Drugs Department for submission of applications, obtaining various permissions & approvals, obtaining clinical trial permissions, etc.

POLICY ON POST-APPROVAL STUDIES 1. Post-approval studies may be required to provide additional information on the efficacy, safety, and use of the drug in populations more diverse than included in the clinical trials conducted prior to approval of the new drug in accordance with the provisions of the rules. 2. Necessary guidance documents should o be developed to provide the extent of requirements ...

THE BUREAU OF INDIAN STANDARD (BIS) Is a national standards body in India that operates under the Ministry of Consumer Affairs, Food, and Public Distribution. It plays a vital role in ensuring the quality and safety of products and services. Its main function is to formulates and promote standards to ensure the quality and reliability of products, covering a wide range of industries and sectors. I ...