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RS.S1. – India Regulatory Affairs: Advancing Compliance and Innovation
Session Chair(s)
Manjusha Rajarshi
Founder Regulus Healthcare
Partner at roots-simplified Research and Consulting LLP, India
This session will explore the evolving regulatory landscape in India, focusing on how policy developments, digital transformation, and regulatory reforms are shaping the future of pharmaceutical and biopharmaceutical oversight. Special focus is on regulatory challenges for start-up innovations and new academia-industry partnerships. With an emphasis on enhancing compliance standards while fostering innovation, it will highlight recent initiatives by Indian regulatory bodies, and other key stakeholders. Topics will include efforts to streamline clinical trial approvals, digitize regulatory submissions, and align with international standards. Through expert insights and real-world case studies, the discussion will delve into the practical aspects of maintaining regulatory compliance in a fast-evolving environment, while also encouraging scientific progress and patient access to new therapies. This session is essential for members of innovative start-ups, regulatory professionals, policy makers, and industry leaders navigating the dynamic Indian regulatory ecosystem in healthcare and pharmaceutical world
Speaker(s)
Academia-Industry Collaboration – Regulatory Challenges
Mrutyunjay Suar
KIIT UNIVERSITY , India
CEO, KIIT-TBI
Readiness towards GxP Compliance & Inspections – Data Governance & Data Integrity
Anupama Ramkumar, DrMed
Arkus Research Pvt Ltd, India
Principal Consultant
Quality Compliance & GMP challenges: Ensuring consistency in India Pharmaceutical Manufacturing
Lakshmi Achuta
AshrinBio, India
Strategic Advisor
With the Additional participation of:
Padma V. Devarajan, PhD
SIES School of Pharmaceutical Sciences, India
Advisor Vision & Strategy and Chair Professor
With the Additional participation of:
Kunal Khanna
EffecMed Pvt. Ltd, India
Founder & CEO
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