Business Need

Regulatory Operations teams face significant challenges in managing the submissions activities within life sciences organizations. These include; National differences and changes to submissions requirements (even in the era of the Common Technical Document and the eCTD), fluctuating internal submission workloads, and the coordination of vast amounts of scientific and medical information and data from a wide variety of contributors. Often this needs to be achieved while utilizing all-too-often disconnected IT tools that do not provide an adequate and tightly integrated view of the end-to-end process. Add to this scenario the need to speed new therapies to market while also turning around a variety of post approval submissions related to a portfolio of mature products. These persistent challenges continue to drive Regulatory Operations leads towards creative operating models that provide workforce flexibility, greater efficiency, high quality submissions, and 24 by 7 follow-the-sun global operations.

How Can Navitas Help?

From our State-Of-The-Art Regulatory Processing Center in Chennai, India as well as our South American hub in Columbia, Navitas offers document, report and submission level publishing for both simple and complex submission applications including life cycle management. In addition, Navitas also provides invaluable subject matter expertise in evolving electronic submissions standards, health authority specific guidelines and processes. We have extensive electronic submissions experience gained from serving a wide range of customers and life sciences companies across the globe.

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