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D. Saha
Department of Pharmacy, BGC Trust University Bangladesh, Chittagong
Medicine & Pharmacology

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REGULATORY INFORMATION MANAGEMENT: Novel Approaches for Health Care System Saha, D.
BALI MEDICAL JOURNAL Vol 2 No 3 (2013): Vol.2, No.3, September-December 2013
Publisher : BALI MEDICAL JOURNAL

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Abstract

In managing chemistry, manufacturing and controls documents; the larger process is involved for electronic regulatory submissions to health authorities. This is a case of an entire process standard providing significant gains in efficiency. A solution is needed for this area of the biopharmaceutical industry. Within a Regulatory affiars, there are Information Management needs, particularly related to the electronic Common Technical Document (eCTD) submission process. There are a number of methods for adding efficiencies to the submission process, particularly through automation and standards. Consider the overall process of a sponsor producing an eCTD submission and within it the specific process of transferring Chemistry, Manufacturing and Controls (CMC) documents from a manufacturer to the sponsor. Keeping in mind the overall eCTD process, consider the specific CMC process to illustrate where and how inefficiencies can be changed.
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