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Sugam builds a comprehensive database of the various permissions and licenses issued by S...

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

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Note: Configuration management is a means by which identification and traceability can be...

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7.5.1.1 General requirements The manufacturer shall plan and carry out production and serv...

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Our business is based on high standards, trust, and personalized attention to all projects...

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10.As provided in the rules, surrogate marker should be considered as an interim data poin...

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

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