what is dossiar ? How can I submit to the regulatory
department ?
Answer Posted / 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 View All Answers
how many clauses are there in iso? give me the clauses details?
Tell us about your oncology experience.
WHAT IS MEANING OF DEAIATION WITH EXAMPLE
concomitant administration of 6-mercaptopurine and which product results in severe bonemarrow suppression?
What interests you about the position of Medical Librarian in our company?
why nitrogen charecter as a inert gas plz identified
What are your intentions towards the uplift of the hospital.
What are the regulatory commitments in markets like USA, Canada, Europe, Brazil, South Africa and Japan
What r the different sop in or plant
Iam a B.PHARMA GRADUATE from DELHI UNIVERSITY and I am looking forward for DRUG INSPECTOR EXAM..kindly mail me any ques papaers reg the same...
What experience do you have in training?
what is the leak test procedure of filled bottles (liquid)
What are the filing requirements for ANDA-USA, Europe, Brazil, South Africa, Japan and Emerging Markets
what is the mechanism of action of local anaesthetics?
Can any one tell me that which brand hplc column is used for levetiracetam imp- b test.