Dossier Preparation As Per CTD Format | Regulatory Affairs | NDA | ANDA | MAA

In this lecture, we discussed how to prepare pharmaceutical dossiers as per common technical document (CTD) format for submitting various types of applications such as New drug application (NDA), Abbreviated new drug application, and marketing authorization application (MAA) to the regulatory agency.

We discussed the following:
Common technical document (CTD)
CTD Modules types
Module 1- Administrative and Prescribing Information
Module 2- CTD Summary
Module 3- Quality
Module 4- Non-clinical Study Reports
Module 5 - Clinical Study Reports

My other videos related to Pharmacy/Regulatory Affairs:
Basic Concepts of Pharmaceutical Regulatory Affairs | Drug Regulatory Affairs Interview Questions

Introduction to General Pharmacology | Basics of Pharmacology | Pharmacy | NEET PG | Part 1 | Hindi

Routes Of Drug Administration Of General Pharmacology For Pharmacy, Medical | PART 2 | Hindi

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Thanks for watching this video !!!!!!!!

[elizabethholloway]

Thank you for such a clear and concise explanation. Appreciate it!

[MastersRk]

Thank you sir for this grateful and concise knowledge about CTD

[priyankagulve]

Thank you sir....

It's Very short and easy to understanding

[Swadaksh]

I know I watched too late but, this video is very informative for people who preparing for RA interview... Sir please make video on ICH Q8 as well and many more RA videos. Thank you

[darshanasolanki]

It's is really helpful sir keep going and please share e-ctd . Thanks

[RashidAlrashaid]

Thank you very much it was really helpful.

[poojasadgir]

Plz show the actual document of Ctd and actd as like industrial format so it's better to understand

[ashwagmukaram]

We need to know the contents of each item in detail, from tests and information in a clear manner.

[letsstart]

Kindly show some kind of filled ctd dossier

[sylveriaegbujua]

Thanks, sir for this wonderful and educative video. As a pharmacology student, Can I work in Regulatory affairs with my degree? Thank you

[pateljeel]

Can you share a how to prepare dossier for NDA APPLICATION in INDIA ?.

[SravaniNatakam]

Could u post ASMF and MAA topics in RA

[Viral_Shorts_.-ww]

Please provide this 'CTD Draft' PPT

[ankitapatil]

Sir want your guidance what should I do after my graduation in pharmacy. Should I go for PG in QA or regulatory affairs. OR PG diploma course in clinical data management / covigillance

[dheerajsharma-okvl]

Sir i have done my msc in organic chemistry and currently working in quality control, can i join RA department in pharmaceutical companies or IT Companies

[shirishareddyvlogskurnool]

Very useful 👌 subscribed, bell hitted thankyou

[priteshgahine]

Sir, I want more Information Related to these topic and Domain (Regulatory Affairs) you are describing so smoothly and it is so understandable.
We got only 2 Videos on these sir.
We will really appreciate, if you made a Video on our Request.
Thank you Sir for your Support and Guidance.
Thanks a Lot Sir

[prathameshkundale]

Please share your LinkedIn profile link