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 with 5 years…

Maureen Johnson, RN

Founder, Senior Vice President of Consulting Resources & Operations

Maureen Johnson is a research nurse and medical writer with a unique combination…

Debe Deck

Founder, Senior Vice President of Program Mgmt & Client Services

Debe Deck is a regulatory affairs professional specializing in both FDA and international regulatory…

Kimberly Krueger, JD

Director of Operations

Kimberly Krueger is an attorney with a background in banking and tax law and small business…

REGULATORY PATHWAYS GROUP

Regulatory Strategy Team Members

Lee Kramm MD, MSE

Lee Kramm is a Board-certified ophthalmologist and regulatory professional with 5…

Debe Deck

Debe Deck is a regulatory affairs professional specializing in both FDA and international regulatory…

Anne-Marie Ripley

Anne Marie Ripley consults in the medical device industry, focusing primarily on clinical and regulatory…

Maureen O’Connell

Maureen O’Connell is a regulatory affairs professional specializing in FDA medical device…

Tonya Porter, MS

Tonya Porter, MS has a diverse background in the medical device industry, spanning product…

Ginger Clasby, MS

Ginger Clasby, MS is a clinical and regulatory professional with extensive experience in medical…

REGULATORY PATHWAYS GROUP

Regulatory Affairs Team Members

Maureen Johnson, RN

Maureen Johnson is a research nurse and medical writer with a unique combination of expertise…

Greg Spooner, PhD

Greg Spooner, PhD is a physicist by training with experience developing medical lasers, medical devices…

Gary S. Mocnik

Gary S. Mocnik has regulatory, quality, and R&D experience in diverse medical device product lines and technical…

Debbie Richards

Debbie Richards is a labeling and useability specialist, helping companies ensure that labels…

Amanda Culver

Amanda Culver is a Regulatory Submission Specialist and Document Manager for…

REGULATORY PATHWAYS GROUP

Clinical Team Members

Lee Kramm, MD, MSE

Lee Kramm is a Board-certified ophthalmologist and regulatory professional with 5…

Maureen Johnson, RN

Maureen Johnson is a research nurse and medical writer with a unique combination of expertise…

Maureen O'Connell

Maureen O’Connell is a regulatory affairs professional specializing in FDA medical device…

Anne Marie Ripley

Anne Marie Ripley consults in the medical device industry, focusing primarily on clinical and regulatory…

Tonya Porter

Tonya Porter, MS has a diverse background in the medical device industry, spanning product…

Gretchen Neumann

Gretchen Neumann works in the medical industry managing clinical trials. Over her 20-year career…

Sandhya Subramaniam, MS

Sandhya Subramaniam, MS is experienced in the development of ophthalmic products with a…

Ginger Clasby, MS

Ginger Clasby, MS is a clinical and regulatory professional with extensive experience in medical…

REGULATORY PATHWAYS GROUP

Statistics Team Members

Yi-Jing Duh, PhD

Yi-Jing Duh, PhD is a senior statistician and head of statistical services in the medical devices…

Gerry Gray, PhD

Gerry Gray, PhD is a highly accomplished statistician who previously worked at FDA, starting as…

REGULATORY PATHWAYS GROUP

Quality Team Members

Gary Mocnik

Gary S. Mocnik has regulatory, quality, and R&D experience in diverse medical device product lines and technical disciplines…

Rudy Zacher

Rudy Zacher is a research and development engineer with experience progressing medical devices from idea…

Jennifer Asleson

Jennifer Asleson is a long-time consultant in the regulated pharmaceutical and medical device industry…

REGULATORY PATHWAYS GROUP

Medical Writing Team Members

Maureen Johnson, RN

Maureen Johnson is a research nurse and medical writer with a unique combination of expertise…

Drs. Eeke Romo, DSc

Eeke Romo, DSc is a Dutch-trained physician with extensive experience in design and…

Laura Fletcher, PhD

Laura Fletcher, PhD is a medical writer specializing in analyzing data, conducting literature…

Sandhya Subramaniam, MS

Sandhya Subramaniam, MS is experienced in the development of ophthalmic products with a…

REGULATORY PATHWAYS GROUP

Our Subject Matter Experts Team

Rudy Zacher

R&D Engineering & Quality Systems

Rudy Zacher is a research and development engineer with experience progressing medical devices from idea…

Debbie Richards

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

Debbie Richards is a labeling and useability specialist, helping companies ensure that labels…

Jennifer Asleson

Microbiology, Sterilization & Sterile Barrier Systems

Jennifer Asleson is a long-time consultant in the regulated pharmaceutical and medical device…

Greg Spooner, PhD

Laser Physicist

Greg Spooner, PhD is a physicist by training with experience developing medical lasers, medical devices, and photonics…

Maureen Johnson

Medical Device Reporting (MDR)

Maureen Johnson is a research nurse and medical writer with a unique combination of expertise in regulatory submissions, compliance…

Jeffrey Lohre

Biocompatibility, Toxicological Risk Assessments

Jeffrey Lohre is an experienced quality assurance and regulatory affairs professional…

Arkady Glukhovsky, DSc

R&D Engineer

Arkady Glukhovsky, DSc has over 20 years of experience in leading full development cycle…