What keeps regulatory professionals up at night?
Thomson Scientific
November 2006
This article was originally published in the August 2006 issue of European Pharmaceutical Contractor (Acting Managing Editor: John White)
Investment in regulatory information management technology and skills outsourcing is the best way to register pharmaceutical products and ensure they gain market penetration: two ways to make the regulatory professional's life easier and ensure they get a better night's sleep!
Managing the product registration process on paper alone can present many problems for life sciences companies already weighed down by extensive âpaper-trails'. Companies that persist in centering procedures around paper-based processes and submissions suffer from duplication and the storage and retrieval of multiple copies of the paper document, and this can create a significant and unnecessary burden and regulatory risk. By the same token, too many organizations fail to consider the other factors in making product registration work — people and systems. Paper-based or manual processes are poor and risky foundations for a successful product registration; staff not trained on the latest published rules and regulations, is another.