PHARMACEUTICAL WASTE MANAGEMENT IN INDIA

(A) TO PREPARE AN APPLICATION FOR IND SUBMISSION FOR AZILSARTAN TABLET IN USA. (B) TO PREPARE CHECKLIST FOR AZILSARTAN TABLET AS PER USA.

To compare filing process of NDA of different countries of India, US and Europe. B) Preparation of global list documents of registration of IND and NDA as per USFDA and Europe.

To perform Analytical method validation of Paracetamol and Ibuprofen in pure and tablet form by UV spectrometric method.

(A) To prepare an application for NDA submission for Telaprevir in USA. (B) To prepare NDA checklist for Telaprevir Tablet in USA.

Nation Patenting and Legal Aspects in India and its comparison with Europe & US system and procedure.

To perform Analytical method validation of Paracetamol Tablets by UV-spectrophotometric method.

5. A) To prepare an application for IND submission for Clobazam Tablet in US. B) To prepare IND checklist in us for Clobazam Tablet.

Formal Meetings between the FDA and Sponsors or Applicants

6. (A) To prepare an application for NDA submission for LAMICTAL in USA. (B) To prepare NDA checklist for LAMICTAL Tablet in USA.