February 2010

From the Project Manager's Toolbox: Strategies for eCTD Marketing Application Submissions

Nothing may invoke fear in the heart of new, or even seasoned, regulatory project managers more than the preparation and submission of a marketing application in eCTD format for their company. At first glance, marketing application submissions can appear to be a tedious effort to manage with hundreds of documents and players, and requires orchestrating intricately detailed timelines and intertwined steps. A successful filing is possible but requires beginning with the end in mind by planning for and organizing the application's contents and process steps and creatively managing timelines to fully utilize existing resources.

Pharmaceutical, biotechnology and medical device companies that market blockbuster products can earn over $1 billion dollars per year once their products are approved for sale by the United States Food and Drug Administration (FDA). Approval by the FDA can result in rapid approval to market globally. Companies can invest $1 billion dollars or more over the discovery, research, and development phases of their product candidates. Patent protection can be extended minimally by certain strategies of the developing company. Once patents expire, generic products can enter the market at a fraction of the development cost and reimbursement rates of original products.

The purpose of document control systems is to ensure that manufacturers build products that are safe and reliable. ISO and FDA Current Good Manufacturing Practices (CGMPs) presume that both the process and documentation that directs company processes follows pre-approved methods and that any change to these methods is restricted to authorized personnel and tracked for future review. All FDA-regulated and ISO-certified companies are mandated to have a document change control system.

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Do you know the history of the Food, Drug and Cosmetic Act? The history began in 1883 when Harvey Washington Wiley, Chief Chemist of the Bureau of Chemistry at the U.S. Department of Agriculture, became the main crusader of food standards. The concerns related to the adulteration and misbranding of foods embolden him to form the famous "Poison Squad," which tested the safety of preservatives in food.
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