Uncovering

Lean Development Path

In the fast-paced world of pharmaceuticals, finding the most efficient pathway to market is crucial. Our strategic consulting services are designed to streamline your drug development process, ensuring a lean, cost-effective journey from concept to market.

Uncovering

Lean Development Path

In the fast-paced world of pharmaceuticals, finding the most efficient pathway to market is crucial. Our strategic consulting services are designed to streamline your drug development process, ensuring a lean, cost-effective journey from concept to market.

Uncovering

Lean Development Path

In the fast-paced world of pharmaceuticals, finding the most efficient pathway to market is crucial. Our strategic consulting services are designed to streamline your drug development process, ensuring a lean, cost-effective journey from concept to market.

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
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

A team of experts with
a wealth of
industry knowledge and
experience.

A team of experts with a wealth of
industry knowledge and experience.

Committed to Superior Outcomes

Commitment to delivering results that
exceed expectations.

Commitment to delivering results that exceed expectations.

Don't Settle!

Contact us today to learn how our strategic consulting

services can streamline your path to market.