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