Krishna Sarikonda | Regulatory CMC Director
Rezon Bio

Krishna Sarikonda, Regulatory CMC Director, Rezon Bio

As Regulatory CMC Director at Rezon Bio, Krishna Mohan Sarikonda works closely with clients to develop effective global regulatory strategies, navigate complex CMC requirements and accelerate product development from early-stage programs through commercialization. He supports organizations in advancing their products toward successful regulatory approvals and global market launches.
Krishna is a seasoned Regulatory CMC leader with over 20 years of industry experience, guiding the development, approval, and lifecycle management of complex biopharmaceutical products. His expertise spans biologics, biosimilars, combination products, and medical devices across key global markets, including the United States, Europe, Australia, and Canada.
Throughout his career, Krishna has played a pivotal role in advancing regulatory strategies and securing product approvals from leading health authorities, including s the EMA and FDA. He has extensive experience in global CMC submissions, regulatory compliance, post-approval lifecycle management and cross-functional collaboration to support product commercialization
Prior to joining Rezon Bio, Krishna held senior regulatory roles at Sanofi, Lupin Limited and Biocon Biologics, where he contributed to the development and registration of biologic therapeutics.

Appearances:



Festival of Biologics Day 1 @ 14:50

A New Paradigm for Biosimilar Development Without the Need for Clinical Efficacy Studies

  • Scientific foundation for omitting efficacy studies
  • Regulatory evolution and global convergence
  • Impact on development efficiency and patient access
last published: 22/Jul/26 17:05 GMT

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