1. Tackling the US FDA

2. Indian Pharma companies facing strictures from western regulatory authorities: 1. Ranbaxy 2. Sun pharma 3. Lupin

3. Matrix Laboratoriesa) Hyderabad based pharma companyb)Qualified supplier of HIV drugs to WHO

4. FDAsmart A new york based start up Helps the pharma companies to meet FDA requirements CEO-Mr. Ram J. Balani

5. What does FDA require ? Four Questions which it wants to be answered : 1. Is the Drug or Biological substance safe ? 2. Does the Drug or medical device do, what it says ? 3. Can somebody be held responsible for key decisions and actions ? 4. Are the Company’s results and conclusions believable ?

7. Needs to be fullfilled before getting approval

8. GMP compliance is a continous process and not one time effort

10. Can Conduct Surprise inspection anytime

12. Sessions arre based on the experience of the firms who have achieved FDA standards

13. Online sessions for training of Students

14. Saves the efforts and time of Trainers as well as Trainees

16. Thank you Take care 