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Best Regulatory Affair in Delhi NCR. iv Recall Action Level: The level to which the recall...

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Explanation : Interference studies involve adding the potential interferent to the sample...

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

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ND & CT rules recognize the consideration of surrogate endpoints for approval of new drugs...

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ND & CT rules recognize the consideration of surrogate endpoints for approval of new drugs...

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Medical licenses are regulatory licenses issued to individuals, such as doctors, nurses, p...

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5.4 Planning 5.4.1 Quality objectives: Top management of the manufacturer shall ensure tha...

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5.4 Planning 5.4.1 Quality objectives: Top management of the manufacturer shall ensure tha...

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16.0 Claimed Shelf life: This section should provide information on stability testing stud...

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