What is eCTD? Difference between CTD & eCTD? How it will be
prepared? Need of any Software?
- 2 Answers
- 20810 Views
- Ranbaxy, I also Faced
- E-Mail Answers
Answers were Sorted based on User's Feedback
Answer / rohaan vijay chavan
The guidance on marketing applications for drugs and
biologics, known as the Common Technical Document (CTD), was
finalized by the International Conference on Harmonization
(ICH) in 2003. Today the CTD format is mandatory for
paper-based marketing applications in Europe, Japan, Canada,
and other regions, and is highly recommended by FDA.
The eCTD format has become mandatory in key regions for
electronic submissions. Since January 2010, the European
Medicines Agency has required all applications in the
centralized procedure use the eCTD format. Since January
2008 FDA CDER has required all electronic submissions be in
the eCTD format. FDA CBER requires the eCTD format for
priority review and rolling submissions.
| Is This Answer Correct ? | 41 Yes | 11 No |
Answer / vasanth
common technical document and electronic common technic
document
| Is This Answer Correct ? | 7 Yes | 8 No |
Why we use toluene for resolution in UV calibration?
what does in simple words meant by thermodynamically stable means??
hii me completed b.pharmacy this year2010. i am intrested in drug inspector post, so could u plzz send me the full details for the post!!reply me as soon as possible for my id souji388@gmail.com
What is the process validation?
why we use disodium tartarte for determination of factor in KF titration
i have completed b. pharmacy .i want model papers for drug inspector examination
what is Alcova
In Stability testing if significant change occurs then what will be the action plan?
how to make Enrofloxacin 20% solution & whats remedy to avoid crystal formation in this batch after 15 -20days? Please anybody assist in it
Can you explain the pharmacological mechanism of Alprazolam and how it interacts with the central nervous system?
why wrraping required for Sterilizing articles.
what type of column are used in GC
Pharmacy 
