RegulatoryAccelerator or ₹5,600

Regulatory Affairs: India & Global

How a product gets approved in India and in export markets: the Common Technical Document, CDSCO submission routes, and the query cycle that follows. Built for clinical graduates arguing their way into a B.Pharm-dominated function.

10 hours12 lessonsSome industry context helpsCertificate on completion

₹5,600one payment

Included in Accelerator at ₹1,299 a month, which works out cheaper at two courses or more.

Create an account Compare plans

What it moves on your score

SkillsSpecialty relevanceCareer-transition feasibility

What you can do afterwards

Assemble and check a CTD module set

Choose the right CDSCO submission route

Draft a response to a regulatory query

Argue the case for a clinical degree in a regulatory interview

Curriculum4 modules · 12 lessons

The CTD

1Five modules, and what lives in eachVideo20:00

2Where a clinical degree earns its place: Module 5Video17:00

3Reference sheet: CTD mapNotes

India

4CDSCO routes: new drug, subsequent new drug, importVideo23:00

5The New Drugs and Clinical Trials Rules in practiceVideo19:00

6Reference sheet: submission checklistNotes

Export markets

7What changes between India, the EU and the USVideo22:00

8Variations and change controlVideo18:00

9CTD module assessmentAssessment35:00

Queries

10Reading a query for what it is really askingVideo16:00

11Drafting a response that closes it in one roundVideo21:00

12Query response assessmentAssessment40:00

The first two lessons of every course are open. The rest need Accelerator.

Taught by

Farhan Sheikh

Regulatory director, Anvaya Regulatory

Has filed in India and 22 export markets; hires two clinical graduates a year.

Get started