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?
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 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?
thank you for very informative video!!!!
Great informative video, Thank You!!!
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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?
Video is very helpful to me,kindly provide more information regarding the eCTD format.....
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
what regulation this information is based? EMA FDA? thanks
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.
Plz reach out to ashish in India he will help 8871197937
@@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?
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....
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
what regulation this information is based? EMA FDA? thanks
Europe!