The Innovations That Are Driving Regulatory Affairs

    The role of Regulatory Affairs in helping to bring new products to market quicker is paramount and should not be under-estimated. Cognizant Technology Solutions’ Venu Mallarapu explores some of the latest technologies that are playing a significant role in shaping modern regulatory affairs.

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    The pace of technological change sometimes feels like it grows faster by the day, both in the wider business world and in Life Sciences specifically. From Robotic Process Automation (RPA), Machine Learning (ML) to Blockchain, and dozens more besides, there are many technologies that are having a truly transformative effect on the Life Sciences industry.

    These transformations are taking place in many ways, not least of which in Regulatory Affairs. This is a function of the highest importance within Life Sciences, key to getting the necessary approvals from Health Authorities so a manufacturer’s new products get to market faster and more efficiently. What are some of the trends that are driving change in regulatory affairs?

    Digitization of content

    Moves to digitize content will have benefits in functions all over a Life Sciences firm. Digitized content lends itself to better information, availability and insight into the content, and allows teams to respond to needs and requirements quicker and more efficiently. Methods like Structured Content Authoring are taking roots across various functions that involve content enabling more collaborative contributions and promoting reuse.

    Managing business processes across functional teams 

    In many businesses information is stored in siloes across the organization. This means cross-functional collaboration – increasingly important in Life Sciences – is a significant challenge, leading to inefficiencies in the way disparate teams and functions work with each other. A process like CMC Variation management of a product cannot function unless a lot of line functions come together. However, many a times this critical integration of business processes and systems is inefficient and manual leading to many errors and compliance issues.

    Integration of systems and processes

    Integration of the many systems within Life Sciences organizations can only have a positive impact on regulatory affairs teams. Regulatory Affairs cannot function without matrixed collaboration of various line functions like Product Supply, Safety, Clinical etc. this necessitates the systems used by these teams to be well integrated. Seamless integration makes for improved exchange of information and a better view of end-to-end processes and data. This provides a better information exchange, helping to eliminate inefficiencies.

    Tech innovations themselves

    The fourth major innovation theme is the actual technological innovations themselves – artificial intelligence (AI), intelligent automation, Blockchain. Blockchain is a good example. It’s a technology made popular by the Bitcoin cryptocurrency yet is rich in potential for innovation in Life Sciences and the rest of the business world too. It offers high security of information, the ability to track the provenance of any transactions and facilitates collaboration across different organisations. Some of these elements could be invaluable to Life Sciences organizations.

    These four trends and how they are leveraged for regulatory affairs will dominate industry discussion over the next few years. From my conversations with clients there is huge interest in such developments, and I am keen to explore these even further, shedding more light on innovation trends and how they can be utilized for Regulatory Affairs.

    Have questions about Regulatory Affairs?  AMPLEXOR can help, contact us. 

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    Published on 17/07/18    Last updated on 18/07/18

    #Life Sciences, #regulatory affairs

    About the author

    Venu Mallarapu is head of Regulatory Affairs Advisory consulting at Cognizant. He is responsible for the team that works with 27 of the top 30 Pharmaceutical, 9 of the top 10 Biotech, 10 of the top 10 medical devices companies’ Regulatory Affairs groups. His team provides consulting services to advise clients in Business Process Transformation, IT Strategy & Roadmap, Operational Excellence and Technology Innovation. He has 20+ years of experience in providing thought leadership, business & IT transformation advise and strategic consulting services to clients across the globe. Venu has extensive experience in Clinical, Regulatory, Safety, Quality & Compliance space in Life Sciences R&D.

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