Pharmaceutical companies' regulatory affairs units are more vital than ever, but, traditionally, they have not been known for their flexibility. Peter Lassoff explains why this image is outdated, and how working more co-operatively with your regulatory department will help to maximize your success in the market place. Experienced regulatory professionals are a very valuable resource for development in a variety of ways. Recently we have seen some dramatic failures to obtain regulatory approval in large blue-chip companies; the quest to find the new aspirin or warfarin is as difficult as ever, and even the largest companies are now reconsidering regulatory strategy as a result.Back in those prehistoric times, Regulatory (or 'Registration', as it was then) was more or less a 'post office,' and the work essentially involved compiling reports written by the experts in R&D and mailing them to the various regulatory authorities.The modern view of regulatory affairs is as a dynamic, business-oriented unit, focused on getting products to the market with a commercially viable label, as quickly as possible and for the least possible expense. Regulatory is involved at a very early stage in the development process, often helping with 'portfolio management,' choosing which products should progress to the clinic.
Source: Strategic RA Consulting
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