KPE-C-053 Fundamental Training on Drug Master File Preparation & Submission
Posted on09 May 2015
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Drug Master File summarizes the essential elements pertaining to facilities, processing, manufacturing components, packaging and storage for products associated with pharmaceutical product... Read More
KPE-C-052 Fundamental Training on ANDA Submission and Handling FDA Expectations
Posted on09 May 2015
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Regulatory Norms are ever-changing. There have been significant changes in FDA expectations of Abbreviated New Drug Applications (ANDAs) since the passage of... Read More