General Introduction to Regulatory Affairs

Code of Federal Regulations

Impact of GMP in Regulatory Affairs

Introduction to ICH and the scenarios involved in it

Dossier preparation for filling to a Regulatory Authority

Technical packages in Regulatory Affairs

US market and its Regulations

European market and its Regulations

ROW (Rest of The World) market and its Regulations

Difference between an applicant part and the restricted part in a DMF

DMF (Drug Master File)

Good Regulatory Compliance Practices (GRCP)

Introduction to various schedules of the Drugs and classification

NDA (New Drug Approval)

IND (Investigational New Drug)

ANDA (Abbreviated New Drug Approval)

WHO guidelines and its relevance in international registration.

Regulatory Aspects of Contracts Manufacturing

Analytical Method Validations

Life Cycle of Drug Regulations (LCDR)

ICH Guidelines for Impurity Profiling

Electronic Common Technical Document Submissions

Common Deficiencies in Regulatory submissions

Schedule X Drugs

Schedule Y Drugs

Categorization of Drugs based on schedules A-Z

Residual Solvents impact in Regulatory filing

Impurity Profile impact in Regulatory filing

Generalized data present in Module 1 of CTD

Impact of BA/BE studies in a Regulatory Filing