505B(2) Application Submission
Posted on30 Mar 2018
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The 505(b)(2) new drug application (NDA) is one of three U.S. Food and Drug Administration (FDA) drug approval pathways. The pathway was... Read More
Introductory Training in Drug Regulatory Affairs
Posted on15 Jun 2015
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Course Objectives: The Regulatory Affairs department is an important part of the organisational structure of pharmaceutical companies. Internally it liaises at the interphase... Read More
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
483 Observation by USFDA & it’s implications
Posted on23 Mar 2015
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This course is designed to provide participants with an understanding of the parameters, approaches, and concerns of FDA inspections, and the tool... Read More
Pharma Brand Identity Creation and Protection
Posted on14 Jan 2015
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Branding plays vital role in Pharmaceutical industry and indeed pharma companies are spending huge for designing brand logo, which provides identity for... Read More