1Case studies (4 Nos.) of each of Good Pharmaceutical Practices.
2Documentation for in process and finished products Quality control tests for Solid, liquid, Semisolid and Sterile preparations.
3Preparation of SOPs, Analytical reports (Stability and validation)
4Protocol preparation for documentation of various types of records (BMR, MFR, DR)
5Labeling comparison between brand & generics.
6Preparation of clinical trial protocol for registering trial in India
7Registration for conducting BA/BE studies in India
8Import of drugs for research and developmental activities
9Preparation of regulatory dossier as per Indian CTD format and submission in SUGAM
10Registering for different Intellectual Property Rights in India
11GMP Audit Requirements as per CDSCO
12Preparation and documentation for Indian Patent application.
13Preparation of checklist for registration of IND as per ICH CTD format.
14Preparation of checklist for registration of NDA as per ICH CTD format.
15Preparation of checklist for registration of ANDA as per ICH CTD format.
16Case studies on response with scientific rationale to USFDA Warning Letter
17Preparation of submission checklist of IMPD for EU submission.
18Comparison study of marketing authorization procedures in EU.
19Comparative study of DMF system in US, EU and Japan
20Preparation of regulatory submission using eCTD software
21Preparation of Clinical Trial Application (CTA) for US submission
22Preparation of Clinical Trial Application (CTA) for EU submission
23Comparison of Clinical Trial Application requirements of US, EU and Japan of a dosage form.
24Regulatory requirements checklist for conducting clinical trials in India.
25Regulatory requirements checklist for conducting clinical trials in Europe.
26Regulatory requirements checklist for conducting clinical trials in USA