Events
Regulatory Strategies and Best Practices for Agri-Biologicals
The session will help agri-input startups and innovators navigate India’s regulatory landscape for fertilizers, pesticides, and agrochemicals, featuring insights from Dr. Sawan Kumar (Sea6 Energy) and Dr. Renuka Diwan-Karandikar (BioPrime Agrisolutions). Read more
Navigating FDA Premarket Notifications (510k) and Preclinical Testing:Practical Guide for Indian MedTech Start-ups
Join us for a practical guide on navigating the FDA 510(k) submission process and preclinical testing, tailored for Indian MedTech start-ups. Learn key regulatory pathways, predicate selection, preclinical testing strategies, and tips to make your submission reviewer-friendly with real-world examples. Read more
Understanding FDA’s Documentation Requirements for Software as Medical Device (SaMD)
Join us for a session on understanding FDA’s documentation requirements for Software as a Medical Device (SaMD), covering regulatory pathways, key submission documents, and SDLC alignment with IEC 62304. Followed by exclusive one-on-one mentoring slots for personalized guidance. Read more
MedTech:Doing Business in the USA
Talk on “MedTech: Doing Business in the USA” by Aditya Ingalhalikar, Ph.D. (Founder & CEO of BioAlign Inc.,USA) Read more
Awareness Talk on FDA’s QMSR Final Rule
Awareness Talk on the FDA’s Quality Management System Regulation (QMSR) Final Rule for medical device manufacturers. Read more