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

[@elizabethholloway6945]

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

[@priyankagulve1163]

Thank you sir.... It's Very short and easy to understanding

[@Masters007Rk]

Thank you sir for this grateful and concise knowledge about CTD

[@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

[@poojasadgir7659]

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

[@EducationTricks99]

Thanks for your suggestion I will try

[@anuptambuskar]

Sir plz make a detailed video on ICH guidelines ... Ur videos are very understandable and language is so clear to understand

[@aaromalsatheesh1413]

www.fda.gov/media/150309/download

[@officialpravin1110]

Still waiting

[@darshanasolanki4978]

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

[@user-fu9ts1eo1i]

Thank you very much it was really helpful.

[@user-od8ik1kh5w]

Very nice information sir

[@muazhababa6858]

all the respect Sir

[@sofiaguzzarlamudi7933]

This is really helpful

[@letsstart4505]

Kindly show some kind of filled ctd dossier

[@alijamali.rasupport.official]

Great Information

[@EducationTricks99]

Glad it was helpful!

[@TheWeirddd]

Please provide this 'CTD Draft' PPT

[@ArvindYadav-ty7hm]

Very nice

[@pateljeel8589]

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

[@sylveriaegbujua1730]

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

[@shirishareddyvlogskurnool6605]

Very useful 👌 subscribed, bell hitted thankyou

[@earththrill2541]

This is very informative video❤️

[@priteshgahine1970]

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

[@shjaswal6857]

Thanks for sharing sir

[@venkataratnams5406]

Nice sir

[@priyankakekan5024]

But how to learn all the models..??

[@ankitapatil8676]

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

[@shjaswal6857]

Really informative

[@dheerajsharma-ok4vl]

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

[@karan0182]

Are you prepared Dossier..??

[@kamsalinagaraj9856]

😱

[@prathameshkundale3813]

Please share your LinkedIn profile link