ANALOG LABS
EWS-729, Road no: 3, KPHB colony, Kukatpally, Hyderabad-500072
E.mail: kandulabhavishya791@gmail.com
For Details & Registration call: 9949995487/9440483170
1. Pharma Regulatory Affairs Training Duration: 30 hrs
(Online Training is also available)
2. Overview
3. Country Wise Regulations, regulatory systems and regulatory agencies
a) Regulated countries
b) Semi regulated countries
c) Non regulated countries
4. Types of Drug Applications
a) DMF (Types)
b) ASMF
c) IND
d) NDA
e) ANDA
5. Preparation of Drug Applications (Dossiers) in Different formats
a) CTD
b) ACTD
c) eCTD
6. Importance of stability studies while submitting dossiers
7. Importance of Impurity profile (Related Substances) while submitting dossiers
8. Bioavailability and Bioequivalence studies (BA & BE)
