Authors:

D. Saha

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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PDF:

https://jurnal.harianregional.com/bmj/full-6960

Published

2013-09-04

How To Cite

SAHA, D.. REGULATORY INFORMATION MANAGEMENT: Novel Approaches for Health Care System.BALI MEDICAL JOURNAL, [S.l.], v. 2, n. 3, sep. 2013. ISSN 2302-2914. Available at: https://jurnal.harianregional.com/bmj/id-6960. Date accessed: 28 Aug. 2025.

Citation Format

ABNT, APA, BibTeX, CBE, EndNote - EndNote format (Macintosh & Windows), MLA, ProCite - RIS format (Macintosh & Windows), RefWorks, Reference Manager - RIS format (Windows only), Turabian

Issue

Vol 2 No 3 (2013): Vol.2, No.3, September-December 2013

Section

Articles

Creative Commons License This work is licensed under a Creative Commons Attribution 4.0 International License