1Case studies on
2Change Management/Change control. Deviations
3Corrective & Preventive Actions (CAPA)
4Documentation of raw materials analysis as per official monographs
5Preparation of audit checklist for various agencies
6Preparation of submission to FDA using eCTD software
7Preparation of submission to EMA using eCTD software
8Preparation of submission to MHRA using eCTD software
9Preparation of Biologics License Applications (BLA)
10Preparation of documents required for Vaccine Product Approval
11Comparison of clinical trial application requirements of US, EU and India of Biologics
12Preparation of Checklist for Registration of Blood and Blood Products
13Registration requirement comparison study in 5 emerging markets (WHO) and preparing checklist for market authorization
14Registration requirement comparison study in emerging markets (BRICS) and preparing checklist for market authorization
15Registration requirement comparison study in emerging markets (China and South Korea) and preparing checklist for market authorization
16Registration requirement comparison study in emerging markets (ASEAN) and preparing checklist for market authorization
17Registration requirement comparison study in emerging markets (GCC) and preparing checklist for market authorization
18Checklists for 510k and PMA for US market
19Checklist for CE marking for various classes of devices for EU
20STED Application for Class III Devices
21Audit Checklist for Medical Device Facility
22Clinical Investigation Plan for Medical Devices