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Uttar Pradesh Drugs and Pharmaceutical Company Ltd (UPDPL), Lucknow is the only public sector drug manufacturing
company of Uttar Pradesh. The plant functions at WHO/GMP guidelines. The challenging landscape is largely a result of
the success of the biopharmaceutical industry in delivering medical therapies for many disease states, safety catastrophes from
use of products post-approval; and product quality compliance issues. These have sharpened regulatory authorities? focus on
product benefit/risk profiles and related stakeholders? views on cost effectiveness and patient access. The regulatory professional
has to be equipped and poised to effectively guide the organization to success with a credible voice, informed strategic guidance
and objective evaluation. The scope of the regulatory affairs group function spans the entire spectrum of product development,
manufacturing, registration, post-marketing activities and lifecycle optimization. This span of involvement and responsibility is
sometimes referred to as bench to bedside and beyond, from cradle to grave, from inception through lifecycle optimization, from
laboratory to launch, etc. The regulatory team and professional hold a unique position of importance with impressive diversity
in function and significant breadth and depth of responsibility. Key functional units are Product development, Chemistry,
manufacturing and control, Policy and regulatory intelligence, Regulatory submission, Product labeling and Promotion and
advertising which are having their own key roles and strategic elements of global regulatory contributions.
Shivendu Ranjan is in B.Tech Biotechnology Final year at the age of 21 years from VIT University, Vellore, Tamil Nadu. He has published 3 papers
in peer reviewed journals. He was the Student Organizer of VIT Biosummit?12, a meet between industrialists and academia. He was Manager/
Co-Organizer of graVITas?12 (College Technical Fest). He was also student coordinator in many college tech and cultural fests. He has good
presentation skills with leadership and team management skills.
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