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.
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…
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
Vice President of Operations
Kimberly Krueger is an attorney with a background in banking and tax law and small business operations…
Regulatory Strategy Team Members
Lee Kramm MD, MSE
Lee Kramm is a Board-certified ophthalmologist and regulatory professional who served…
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 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 with over 28 years developing medical lasers, medical devices, and…
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…
Clinical Team Members
Drs. Eeke Romo, MSc
Eeke Romo, DSc is a Dutch-trained physician with extensive experience in design and…
Lee Kramm, MD, MSE
Lee Kramm is a Board-certified ophthalmologist and regulatory professional who served…
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 has over 20 years of experience in the medical industry managing clinical projects…
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…
Jane Marie Johnson
Jane Marie Johnson specializes in remote and onsite consulting services for medical device firms with a…
Statistics Team Members
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, MS has a background in medical device engineering primarily in the subjects of Research & Development…
Jennifer Asleson
Jennifer Asleson is a long-time consultant in the regulated pharmaceutical and medical device industry…
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 conducting literature reviews, writing…
Sandhya Subramaniam, MS
Sandhya Subramaniam, MS is experienced in the development of ophthalmic products with a…
Our Subject Matter Experts Team
Rudy Zacher
R&D Engineering & Quality Systems
Rudy Zacher, MS has a background in medical device engineering primarily in the subjects of Research & Development…
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 Physics
Greg Spooner, PhD is a physicist with over 28 years developing medical lasers, medical devices, and photonics instrumentation…
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 Engineering
Arkady Glukhovsky, DSc has over 20 years of experience in leading full development cycle…
Richard Cook
Medical Device Software
Richard Cook is a software and systems engineering expert who works on all phases of the software life cycle…
Arup Roy, PhD
Medical Device Software
Arup Roy, PhD has extensive experience managing technology innovation and helping companies deliver…
Brian Bone, MS
Human Factors Engineering and Usability
Brian Bone, MS is a user-centered design expert specializing in research, design, and user testing of user…
