How Effective Document Management Helps Pharmaceutical Companies Accelerate Time to Market

By Master Control

Introduction

This white paper will discuss common challenges pertaining to document control encountered by most drug companies from the preclinical stage through the post-market phase, and how the MasterControl™ GxP process and document management software solution addresses such challenges to accelerate time to market and improve product quality.

Preclinical Phase

One could say that the years spent by chemists, biologists, pharmacologists, toxicologists, and other scientists “discovering” the right combination of chemical and biological substances that could be used for a drug are geared toward the submission an investigational new drug (IND) application. FDA approval of the IND is necessary to conduct clinical trials and to proceed with product development.

Discovery research scientists typically start with thousands of possible compounds. Through continuous testing, screening, and refining that could take several years, they would whittle down the thousands of compounds to hundreds, and then dozens, and then three to five drug “candidates.” This rigorous phase includes laboratory and animal studies that cover chemistry tests, biological tests, manufacturing tests, and pharmaceutical development studies. The overarching goal during this phase is to determine the safety of the candidates before they are tested in people.

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