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Navigating the Regulatory Landscape for Oligonucleotide Therapeutics: Challenges and Opportunities

26 Sep 2025
Regulatory, Safety & Market Access
  • Understanding FDA, EMA, and CDSCO expectations for oligonucleotide-based therapies and how they differ from traditional biologics
  • Addressing key regulatory requirements in manufacturing, characterization, and control strategies for oligonucleotide APIs and finished products
  • Managing regulatory expectations around safety, biodistribution, and off-target effects in IND and clinical trial submissions
Industry Expert
Tuhin Bhowmick, CEO & Co-founder - Pandorum Technologies