what is dossiar ? How can I submit to the regulatory
department ?



what is dossiar ? How can I submit to the regulatory department ?..

Answer / suvra jyoti dutta

Dossier is a file document submitted for the approval of
drug product.It is submitted in form of CTD to the
regulatory agency. CTD is a harmonized format (template)
for presenting data in the ICH regions.

Is This Answer Correct ?    4 Yes 0 No

Post New Answer

More Health Pharma AllOther Interview Questions

How do you fix the known and unknown impurity limit for a drug substance?

2 Answers   IBM,


what is the test scenario?

1 Answers   CardEx, UHG,


please explain the job responsibilities of quality assurance..

0 Answers  


How should the Medical Librarian interact with training staff?

0 Answers  


exolain th function of the joints

2 Answers  






diffrence between known impurity and specified impurity?

2 Answers   Cipla, Medreich,


Why SLS used as dissolution medium

0 Answers  


while formulation of Gliclazide floating tablets why we are using direct cmpression technique why not wet granulation and what happend with that

0 Answers  


what is dossiar ? How can I submit to the regulatory department ?

1 Answers  


What is the different between GMP & cGMP ?

1 Answers  


how many deviation allowed

2 Answers   Pentagon Labs,


How do you feel about physical restraints?

0 Answers  


Categories