Our Experts!
With over 80 years of collective experience, our team of experts specializes in navigating the complexities of drug development. We provide tailored strategies that align with your business goals, leveraging the latest advancements in pharmacometrics, artificial intelligence, and machine learning.
Dr. Joga Gobburu, a Drug Development and Regulatory Strategist, is a Professor at the University of Maryland. Before that, his extensive career includes significant roles at the US FDA from 1999 to 2011. His FDA tenure included overseeing thousands of INDs and over 250 licensing applications, forming the Division of Pharmacometrics. Joga's work has earned him numerous awards, including from the American Conference on Pharmacometrics and the American Society of Clinical Pharmacology. He has published over 120 papers and chapters.

Dr. Joga Gobburu
Regulatory Strategist
Joan Korth-Bradley, PharmD, PhD, FCP, FAAPS, a Distinguished Scientist at Vivpro Corp. with over 30 years in drug development, specializing in clinical pharmacology. She has developed medicines in oncology, cardiology, anti-infectives, rheumatology, and rare diseases, working with small molecules, therapeutic proteins, and antibody-drug conjugates. Joan has published over 90 papers and serves on the editorial boards of key pharmacology journals. Her focus at Vivpro AI is using AI to address unmet medical needs, especially in underserved populations. Joan earned her PhD from the University of Texas at Austin and her PharmD from the University of Minnesota, Twin Cities.

Dr. Joan Korth-Bradley
Distinguished Scientist
Dr. Mary Ross Southworth served as Deputy Director for Safety in the Division of Cardiology and Nephrology at FDA’s CDER from 2008 to 2025. As the division’s principal drug safety expert, she guided regulatory and policy decisions across cardiovascular and renal therapies, overseeing safety throughout IND, NDA, and postmarketing stages. Dr. Southworth led initiatives on REMS, safety labeling, and postmarket surveillance, and contributed to programs like the Sentinel Initiative. Previously, she spent four years in the Office of Surveillance and Epidemiology. A clinical expert in cardiology, she served on the Heart Failure and Transplant Service at the University of Illinois at Chicago. She holds a BS Pharm from Virginia Commonwealth University, a PharmD from the University of Toledo, and completed a Cardiovascular Pharmacotherapeutics Residency at the University of Illinois at Chicago.

Dr. Mary Ross Southworth
Regulatory Expert
Dr. Pravin Jadhav, CEO of Vivpro Corp and expert in R&D Intelligence, has 19 years of experience in drug development and regulatory science, holding pivotal roles at the FDA, Merck, and Otsuka. He led significant projects involving over 100 NDAs and 150 INDs. Dr. Jadhav holds a PhD in Pharmaceutical Sciences from VCU and an MPH from Johns Hopkins University. His expertise ensures innovative, science-driven solutions for clinical and economic utility in pharmaceutical development.

Dr. Pravin Jadhav
Drug Development Strategist
We offer Value-Centric Service
Service Excellence designed around user needs to maximize
Probability of Technical and Regulatory Success (PTRS)
Clinical
Development
Strategy
Leverage nonclinical and CMC components to support development plans
Design and execution of Phase I to Phase III clinical trials
Data analysis and interpretation to assess safety and efficacy
Regulatory strategy and submission planning
Identify target indication, dosage form
Regulatory
Strategy
Assistance in regulatory submissions
(Pre-IND, IND, EOP2, NDA, BLA)
Pediatric plans, exclusivity, study designs and efficacy extrapolation
Individual eCTD module development
(2.7.1, 2.7.2, immunogenicity and pediatric summary)
Modeling analysis plans
Unprecedented regulatory decisions
MIDD strategy and execution
Project Optimus support
IB review and optimization
Why Choose Us?
Track Record
of Triumph
Proven track record of successful drug development and market access.
Solutions Tailored
for You
Custom solutions
designed for
your unique needs.
Expertise at
Your Service
Committed to Superior Outcomes
Don't Settle!
Contact us today to learn how our strategic consulting
services can streamline your path to market.



