How to register or submit drug master file to any regulatory agency?

2 Answers  

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how to calculate potency of working standard by using mass balence method & this calculated potency is on as basis or on anhydrous/ dried basis

0 Answers   Orchid,

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what is the difference between BirdFlu and Common flu?

2 Answers  

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Why 3 validation  batches charge in stability ?is there any specific reason for 3 ?

1 Answers   Torrent Pharma,

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What are the regulatory commitments in markets like USA, Canada, Europe, Brazil, South Africa and Japan

0 Answers  

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using of chemical standards in HPLC he customer gave 100.2% what potency i will use this potency in hplc?

1 Answers   Vivimed Labs,

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why an employee go for medical representative instead of quality?

1 Answers  

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What are your duties in your current position?

0 Answers  

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diffrence between known impurity and specified impurity?

2 Answers   Cipla, Medreich,

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What are the filing requirements for ANDA-USA, Europe, Brazil, South Africa, Japan and Emerging Markets

0 Answers  

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my wife is Pregnant and in scanning report their is a mark ( + )what is that mean?

2 Answers  

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What do you mean by GTT? What are the effect of GTT on film coating.

0 Answers  

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