Preclinical GLP Research Studies for Medical Devices
NAMSA: An Experienced GLP-Compliant Contract Research Organization
Fully Equipped ORs and Cath Labs in US and Europe
Labs in US and Europe Offering Preclinical Services
GLP Preclinical Studies in Last 12 Months
Of Successful FDA PMAs Last Year Supported by NAMSA
GLP Preclinical Studies in a Wide Variety of Therapeutic Areas and Models
The NAMSA team has extensive experience conducting GLP-compliant studies on a vast array of medical devices in the following areas:
- Cardiovascular*
- Dental
- Diabetes care
- Gastroenterology*
- General surgery*
- Neurovascular*
- Ophthalmology
- Orthopedics*
- Peripheral vascular*
- Wound care*
*Extensive expertise in this area
From GLP Compliance to Pivotal Trial Success
NAMSA’s GLP-compliant preclinical studies are designed to ensure complete data integrity, providing the dependable foundation pivotal trials need for regulatory success. Our teams follow methods and regulations established by the European Committee for Standardization (CEN), the U.S. Food and Drug Administration (FDA) and other international authorities to deliver reliable, auditable results.
Understanding the relationship between GLP vs. non-GLP studies is essential when planning a full development program; early feasibility and concept testing can be supported through our non-GLP studies before advancing into GLP-compliant research.
Do We Have Expertise With Your Device?
Want to learn more about our GLP preclinical experience for your specific category of device?
NAMSA Lab Equipment and Facilities
NAMSA offers cutting-edge equipment and techniques. We have numerous digital catheterization labs featuring state-of-the-art Fixed C-arm platforms. We can accommodate your timelines no matter how large the study design or last minute the request. Each cath lab features dedicated workstations for real-time quantitative analysis and evaluation.
See a comprehensive list of equipment here.
WHY CLIENTS CHOOSE NAMSA
The expertise and guidance provided by NAMSA throughout the process were pivotal in the success of our animal implant study. The team’s deep knowledge of the latest research methods and protocols, combined with their support in the creation of precise and ethical study strategies, ensured that we achieved strong and timely results, which led to the successful FDA approval. Their comprehensive understanding of animal welfare regulations and the scientific demands of such studies was highly valuable. Additionally, the support from the teams for the preliminary FDA interactions was particularly helpful, and we greatly appreciated it.
Morgane Le Nan, R&D Manager at NorakerSetPoint’s work with NAMSA has been instrumental to our success. They have been accommodating of our unique needs and provide timely feedback when needed.
Dan Ward, Director of Program Management at SetPoint MedicalMeet Our Preclinical Experts
Explore the depth of our team’s expertise.
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Jack Risdahl, DVM, PhD
Principal Strategy Consultant, PreclinicalView Bio -
Gaëlle Clermont, PharmD, PhD
Principal Strategy ConsultantView Bio -
Michael A. Jorgenson, BS
Principal InterventionalistView Bio -
Tyler LaMont
Senior InterventionalistView Bio -
David Reimer, MD
SurgeonView Bio -
Corey Leet
Director, Regional Preclinical and In-Vivo Biocompatibility OperationsView Bio
Other Preclinical Services That May Interest You
Non-GLP Studies
Pathology Services
