About Us
We are proud to have assembled a world-class team that brings more than 200 years of combined success
Regulatory Pathways Group has assembled a team of more than 30 consultants. Our consultants come from diverse backgrounds in industry, academia, medicine, and regulatory agencies.
Many of our consultants have worked together closely for years, giving Regulatory Pathways unique cohesion and synergy. As individuals, our experts offer specific and narrowly focused knowledge and functional expertise, but when combined, we bring a holistic perspective from overlapping years of practical experience and teamwork. We are passionate about our craft and we strive to generate value for our clients.
REGULATORY PATHWAYS GROUP
Executive Team

Lee Kramm MD, MSE
Founder, President, Chief Strategist and Medical Officer
Lee Kramm is a Board-certified ophthalmologist and regulatory professional who served as a medical officer and senior reviewer…

Maureen Johnson, RN
Founder, Senior Vice President of Consulting Resources & Program Management
Founder, Senior Vice President of Consulting Resources & Program Management Maureen Johnson is a research nurse and medical…

Kimberly Krueger
Vice President of Operations & Client Services
Kimberly Krueger is an attorney with a background in banking and tax law and small business operations……
REGULATORY PATHWAYS GROUP
Regulatory Strategy Team Members
REGULATORY PATHWAYS GROUP
Regulatory Affairs Team Members
REGULATORY PATHWAYS GROUP
Clinical Team Members
Drs. Eeke Romo, MSc
READ MORELee Kramm MD, MSE
READ MOREDon Calogero, MSE
READ MOREMaureen Johnson, RN
READ MOREMaureen O’Connell
READ MOREAnne Marie Ripley
READ MORETonya Porter
READ MOREGretchen Neumann
READ MORESandhya Subramaniam, MS
READ MOREGinger Clasby, MS
READ MOREKelly Soprych
READ MORE
REGULATORY PATHWAYS GROUP
Statistics Team Members
REGULATORY PATHWAYS GROUP
Quality Team Members
REGULATORY PATHWAYS GROUP
Medical Writing Team Members
REGULATORY PATHWAYS GROUP