what is dossiar ? How can I submit to the regulatory
department ?
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.
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are vaccines for long term or short term?
2 Answers GSK GlaxoSmithKline,
What is difference between Warm and Lukewarm Water as per pharmacopia.
Give an example of how you've handled a problem patient.
Which types of deviations are followed in pharmaceuial API manufacturing industry?
how many deviation allowed
What is the difference between Deviation and Out of Specification ?
what is immunity?
5 Answers GSK GlaxoSmithKline,
What is difference between Analytical method validation and Analytical method transfer?
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Why 3 validation batches charge in stability ?is there any specific reason for 3 ?
What are the filing requirements for ANDA-USA, Europe, Brazil, South Africa, Japan and Emerging Markets
while formulation of Gliclazide floating tablets why we are using direct cmpression technique why not wet granulation and what happend with that