ISSN: 2041-6792

Clinical Investigation

Regulatory Affairs Innovations

The role of Regulatory Affairs in helping to bring new products to plug quicker is paramount and will not be under-estimated. Cognizant Technology Solutions’ Venu Mallarapu explores a number of the newest technologies that are playing a big role in shaping modern regulatory affairs. These transformations are happening in some ways, not least of which in Regulatory Affairs. This is often a function of the very best importance within Life Sciences, key to getting the required approvals from Health Authorities so a manufacturer’s new products get to plug faster and more efficiently. Moves to digitize content will have benefits in functions everywhere a Life Sciences firm. Digitized content lends itself to raised information, availability and insight into the content, and allows teams to reply 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. In many businesses information is stored in siloes across the organization. This suggests cross-functional collaboration – increasingly important in Life Sciences – may be a significant challenge, resulting in inefficiencies within the way disparate teams and functions work with one another. A process like CMC Variation management of a product cannot function unless tons of line functions close. However, many a times this critical integration of business processes and systems is inefficient and manual resulting in many errors and compliance issues.    

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