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 ?