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4.2 Documentation requirements 4.2.1 General: The quality management system documentation ...

2023-10-10T04:28:46

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What are the requirements for import of Class-A/B/C/D In Vitro Diagnostic Medical device ...

2023-10-31T12:24:26

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We have a young professional team working on regulatory submissions for pharmaceutical pro...

2023-12-12T05:08:52

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6. However, accelerated approval should be used for a drug that represent significant adva...

2023-10-28T05:47:30

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BACKGROUND 1. Import or manufacture for sale of drugs are regulated under Drugs and Cosmet...

2023-10-28T05:40:49

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Such discussion to help the reviewers becomes acquainted with the information to be includ...

2023-10-26T11:10:29

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BACKGROUND 1. Import or manufacture for sale of drugs are regulated under Drugs and Cosmet...

2023-10-26T05:38:50

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POLICY ON NEW DRUG APPLICATION: 1. The content of New Drug Application (NDA) should be des...

2023-10-25T05:12:05

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(a) the manufacturer shall establish documented requirements for health, cleanliness and c...

2023-10-11T04:52:42

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