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

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

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15.However, detailed guidance documents should be prepared providing the requirements and ...

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

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PRESENTATION AND SUBMISSION OF APPLICATION 1. In order to make regulatory review process a...

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Regulatory Services Our clientele consists of numerous local and international manufacture...

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The clients receive outstanding value from accredited Consultancy's high-quality, affordab...

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Accredited Consultants Pvt. Ltd. The clients receive outstanding value from accredited Con...

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As part of design and development validation, the manufacturer shall perform clinical eval...

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