Pharma Regulatory Services

Deals with Drug regulatory filing and subsequent approval processes of drugs in India as well as other regulatory countries. Drug filing process includes complete technical and administrative review of the data submitted. This helps to reduce the concerns raised by the regulators and helps to expedite the approval process. 

Apart from drugs, our regulatory services are extended to cosmetics, medical devices, ethics committee registration etc. Additionally, we have separate and dedicated teams handling the layout designing of drugs and nutraceuticals manufacturing plants as per GMP requirements of USFDA, MHRA, EU, TGA, PIC/S, WHO, Schedule M etc.

List of Services:

1 Regulatory Pharma

2 New Drug Approval

3. DCGI Approval

4. FDC approval

5. Cosmetic Approval

6. Medical Device approval

7. Ethics Committee registration

8. GMP trainings

9. conduct third party audits, 

10. legal services

11. helps in QMS implementation

12. project management

13. Regulatory retainership

14. support as Authorized agent

15. product distribution