Biology White Papers
FDA E-submissions Solutions for New Drug Applications (NDA) and Biologics License Applications (BLA)
Overview
In order for businesses to stay on top in an Internet-paced environment, they must work smarter and more efficiently. The inability to effectively manage complex documentation to meet regulatory compliance and new product approval - with increasing regulatory demands - are major factors in slowing the time it takes to bring a product to market. These delays cost companies hundreds of thousands of dollars in potential lost revenue.
The 1997 release of the final ruling of 21 CFR Part 11 outlines FDA guidelines for accepting electronic documentation and electronic signatures. This ruling opened the door for the life sciences industry to bring products to market faster by allowing electronic submissions for New Drug Applications (NDAs) and Biologics License Applications (BLAs).
| Publisher | Document Control Systems Inc. | File Format | PDF, requires Acrobat Rdr 5 |
|---|---|---|---|
| Date Published | January 2002 | Downloads | 495 |
| Format | White Papers | ||
| Topics | |||
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