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14.0 Definition of Assay Cut-off: This section should provide a summary of analytical data...

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

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

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After the NDA is accepted the various section of the application should undergo concurrent...

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Note: 1. All the test reports submitted as a part of the dossier should be signed and date...

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18.0 Shipping stability: This section should provide information on shipping stability stu...

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17.0 In use stability: This section should provide information on in use stability studies...

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

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

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