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

Maureen Johnson, RN

Founder, Senior Vice President of Consulting Resources & Operations

Debe Deck

Founder, Senior Vice President of Program Mgmt & Client Services

Kimberly Krueger, JD

Vice President of Operations

REGULATORY PATHWAYS GROUP

Regulatory Strategy Team Members

REGULATORY PATHWAYS GROUP

Regulatory Affairs Team Members

REGULATORY PATHWAYS GROUP

Clinical Team Members

REGULATORY PATHWAYS GROUP

Statistics Team Members

REGULATORY PATHWAYS GROUP

Quality Team Members

REGULATORY PATHWAYS GROUP

Medical Writing Team Members

REGULATORY PATHWAYS GROUP

Our Subject Matter Experts Team

Rudy Zacher

R&D Engineering & Quality Systems

Debbie Richards

Labeling, Usability, Unique Device Identifier (UDI, UDIDI)

Jennifer Asleson

Microbiology, Sterilization & Sterile Barrier Systems

Maureen Johnson

Medical Device Reporting (MDR)

Jeffrey Lohre

Biocompatibility, Toxicological Risk Assessments

Brian Bone, MS

Human Factors Engineering and Usability