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

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

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

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(f) Undertaking signed stating that the manufacturing site is in compliance with the prov...

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(v) details of competent technical staff, under whose direction and supervision the sales ...

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

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

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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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