Regulatory Affairs

REGULATORY FUNCTION:

1. DMF / CTD / CMC Preparation, Review & Submission

2. COS / CEP Preparation, Review & Submission

3. Product Dossier preparation, Review & Submission

4. Handling & Support for regulatory audits

5. DMF preparation and submission to Korea, Japan, Australia, Newzealand and Canada

6. TDP preparation

7. Response to customer and Regulatory queries

8. Manufacturing site accreditation in Japan

9. Risk Analysis

10. Mock audit to ensure effectiveness of systems

ESHYASI PHARMA LTD. has in-house Laboratory with sophisticated equipments as per GMP requirements and support of R & D to provide a total solution to its customers from India and overseas.