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Regulatory CMC for Bio-pharma and Pharmaceuticals 

gourav pandey
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If you like to take more in-depth conceptual and subjective training on these topics refer to my network trainer friends (Ashish Singh-Founder of Pharmalearner.com) this is a group of experience training with years of experience and can help you excel in your professional journey. I will continue to make more videos however if you need help in the detailed subjective topic or customized learning feel free to explore their websites www.pharmalearner.com & Phone (+1 781-483-4964/+91 8871197937)
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Hello every one this video provide over view of Regulatory CMC work structure in actual industry setting. This video help those who may be looking to change their career from existing roles to Regulatory affairs or international or national students who are looking to start their journey in regulatory affairs. If you are currently working in other functions or doing coop or internship try to align your work with details mention in this videos.

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14 сен 2019

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Комментарии : 15   
@gdp2102
@gdp2102 2 года назад
thank you for very informative video!!!!
@daniellef7811
@daniellef7811 3 года назад
Great informative video, Thank You!!!
@azinrostami1721
@azinrostami1721 4 года назад
Hello , very useful video thanks. When you say eCTD software , do you use this software for compiling different parts of CTD that we write together or the software is used for registering the file in EU or FDA portal? If the second one is the case , the can someone submit the file to portal with username and password of company, without use of software?
@rahulrandhavane2075
@rahulrandhavane2075 4 года назад
Video is very helpful to me,kindly provide more information regarding the eCTD format.....
@gouravpandey5623
@gouravpandey5623 4 года назад
HI Rahul can you reach out to Ashish in India for ECTD training , I can help with CMC training that too in USA only. +91-8871197937
@krishnagopalpal523
@krishnagopalpal523 2 года назад
what is the generic name of dexa enema witch made by cmc
@ericabarrosomilner
@ericabarrosomilner 2 года назад
what regulation this information is based? EMA FDA? thanks
@ashiyarafy4442
@ashiyarafy4442 3 года назад
Hi .., I want to learn on Review of technical dossiers of bio therapeutics and vaccines in respect of CMC, Quality control testing of biologicals and IVD etc. I am from biotech vaccine field and want to learn more. Pls help.
@gouravpandey5623
@gouravpandey5623 3 года назад
Plz reach out to ashish in India he will help 8871197937
@ashiyarafy4442
@ashiyarafy4442 3 года назад
@@gouravpandey5623 many thanks Gaurav.. I have 12 years of biotech vaccine R&D experience and I want to learn the regulatory guidelines for bio therapeutics regarding review of technical dossiers, CMC etc . Mr Ashish will help through phone. Should I call him on his number?
@amolasmi
@amolasmi 4 года назад
Hello sir, will you please be so kind and provide me or I can say is some basic of eCTD EU submission Information.... Waiting for your response....
@gouravpandey5623
@gouravpandey5623 4 года назад
HI Ashish can you reach out to Ashish in India for ECTD training , I can help with CMC training that too in USA only. +91-8871197937
@ericabarrosomilner
@ericabarrosomilner 2 года назад
what regulation this information is based? EMA FDA? thanks
@amolmaliwalave908
@amolmaliwalave908 2 года назад
Europe!
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