CSC: The changing face of regulatory outsourcing - Article - By Paul Chung, CSC Life Sciences.

Hit by a perfect storm of heightened regulatory scrutiny and a tougher business climate, life sciences companies are scrambling to find ways to cut costs and expand revenue. This has led to a growing trend across the life sciences industry as all departments, including research and development, are no longer considering if and when they should outsource, but how much.

In a supercharged business and regulatory climate, life sciences companies large and small are turning to outsourcing vendors to manage tactical tasks and help them adopt best practices. In a constrained business environment, companies are finding that good partnerships bring added efficiencies, the potential for greater market share and the skills and capabilities that enable products to be brought to market more rapidly and maintained well in diverse markets.

There are many reasons why companies turn to outsourcing partners: additional capacity, resource flexibility, cost savings, developing a new capability, process improvement and process standardization, to name a few. Given that regulatory submissions have quiet and busy periods, outsourcing offers a cost-effective and flexible way to manage the peaks and valleys without the need to retain a large in-house staff.

The growth of electronic submissions has encouraged companies to turn to outsourcing partners more frequently to manage product submissions. In part, this is a response to the need for additional resources to support affiliates, but it is also a result of electronic submission standardization that has allowed for greater consistency in how submissions are handled across geographies. It means regulatory practices that once were quite fragmented are more streamlined, allowing vendors to step in and manage clients’ submissions quickly and consistently.

While staff at pharma companies frequently handle such tasks as regulatory submissions, vendors do so day-in and day-out for various clients, thereby developing a level of proficiency that no pharma company could hope to emulate.

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