Nandini Devi | Medical Manager, Global Patient Safety and Regulatory
Krystal Biotech

Dr. Nandini Devi Akurathi, MD, is a Drug Safety Physician and Regulatory Affairs professional with over eight years of experience leading global pharmacovigilance, safety surveillance, signal management, risk mitigation, and regulatory compliance activities across clinical development and post-marketing environments. She has extensive expertise in adverse event assessment, expedited and aggregate safety reporting, benefit-risk evaluation, health authority interactions, labeling strategy, and regulatory submissions, including INDs, BLAs, DSURs, PADERs, PSURs/PBRERs, and Risk Management Plans. With specialized knowledge of FDA, EMA, ICH, GCP, MedDRA, and global pharmacovigilance regulations, Dr. Akurathi has supported innovative therapeutics, biologics, medical devices, and regenerative medicine products while maintaining a steadfast commitment to patient safety, regulatory excellence, and lifecycle product stewardship.   As a Medical Manager, Global Patient Safety at Krystal Biotech, Dr. Nandini Devi Akurathi provides medical leadership and strategic oversight for global pharmacovigilance and safety surveillance activities across the product lifecycle, supporting investigational and marketed biotechnology products. She serves as a key Safety Subject Matter Expert (SME), ensuring compliance with global pharmacovigilance regulations and industry standards, including FDA, EMA, ICH, and Health Canada requirements.