Director – Regulatory Affairs & Quality
Dr. Suresh Patil
Regulatory Experience:
- Former Joint Commissioner, Food & Drug Administration (FDA), India.
- 30+ years regulatory experience across pharmaceuticals, medical devices, and biologics.
- Developed regulatory frameworks for novel therapeutic categories.
Industry Contributions:
- Established GMP-compliant manufacturing facilities for multiple leading pharmaceutical companies.
- Guided 50+ products through regulatory approval processes.
- Expert in global regulatory harmonization (ICH, WHO PQ, USFDA, EMA)
Technical Expertise:
- CMC (Chemistry, Manufacturing, Controls) regulatory strategy.
- Quality system design and validation.
- Regulatory dossier preparation for global markets.
- Facility inspection preparedness.
Role at InfiNano: Architecting regulatory strategy for product portfolio, ensuring GMP compliance, guiding quality
system development, and managing regulatory submissions for domestic and international markets.