Mr. Ram Balani

Ram Balani is the CEO and Founder of eSTARHelper LLC, a company specializing in FDA regulatory consulting and Microsoft Partner services. With a strong background in biopharma and medical device regulatory compliance, he has been instrumental in integrating advanced technologies to streamline FDA submission processes. Under his leadership, eSTARHelper has developed tools like SmartSearch, enhancing the efficiency of regulatory submissions by providing full-text search capabilities across FDA guidance documents and regulations.

In addition to his role at eSTARHelper, Balani is a contributing author at MedHealth Outlook, where he shares insights on topics such as the Drug Supply Chain Security Act (DSCSA) and the application of AI/ML technologies in regulatory compliance. His expertise in FDA regulations and commitment to leveraging technology for compliance solutions have established him as a thought leader in the intersection of healthcare and technology.

MBA

St. Louis University, Missouri

CEO and Founder

eSTARHelper LLC (Jan 2020 - Present)

Contributing Author

MedHealth Outlook (December 2007 - Present)

CEO (Innovative Information Solutions)

Pfizer India (1992 - 1995)