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IND/NDA Regulatory Submission Checklist - Guide
This 21 page checklist - guide document provides over 220 items related to performing an effective audit of Chemistry, Manufacturing and Controls (CMC) section of the following:
Click here to view complimentary excerpt
➢Investigational New Product (INDs)
➢IND Amendments
➢ New Drug Application (NDAs)
➢ NDA Amendments
➢ NDA Supplements
➢ Annual Reports
➢Click here to view complete Table of Contents
CHECKLIST ITEMS INCLUDE:
Regulatory Submission – General
-General Content
-Clinical
-Nonclinical
-Manufacturing Procedure
-Stability Data
-Drug Master Files
INDs
-General
-Nonclinical
-Clinical
-Components
-Drug Substance
-Drug Product
NDAs
-General
-Statement of Composition
-Batch Formula/Components
-Drug Substance
-Drug Product
-Parenteral Products – Aseptic Fills
NDA Annual Reports
-Distribution Data
-Labeling
-CMC Section
IND/NDA Regulatory Submission Checklist is only $99.00:
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