1. Documentation in Pharmaceutical industry 2. Generic drugs product development 3. CFR (CODE OF FEDERAL REGULATION) 4. ANDA regulatory approval process 5. NDA approval process 6. Post marketing surveillance 7. US registration for foreign drugs 8. Regulation for combination products and medical devices 9. CTD and ECTD formats 10. Regulatory Guidelines of ICH-Q, S E, M 11. Regulatory requirements of EU, MHRA, TGA and ROW countries 12. Global submission of IND, NDA, ANDA 13. Investigation of medicinal products dossier 14. Regulatory Affairs in Clinical trials 15. Pharmacovigilance safety monitoring