Regulatory information management: novel approaches for health care system

Main Article Content

Dibyajyoti Saha


Regulatory, Information, Management, Health Care System


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.

Abstract 27 | PDF Downloads 14