Experience is crucial for successful preclinical testing of medical devices. As the industry leader in preclinical development, NAMSA has extensive expertise and knowledge in various therapeutic areas. Our preclinical research services cover a wide range of model types, treatments, and implant requirements including Cardiovascular, Dental, Dermal, Electrophysiology, Gastrointestinal, Neuromodulation, Orthopedics, Pulmonary, Urogenital, Wound Healing and more.
Our global teams of experts are highly sought-after for their ability to help Sponsors bridge preclinical safety endpoints to proposed clinical endpoints using data. This allows clinical labs to standardize measurements and obtain expert interpretations of results. NAMSA also offers support for early feasibility testing through non-GLP surgical/interventional studies, which provide iteration and proof of concept before investing in GLP tests.
By conducting non-GLP studies at an early stage of medical device development, the risk of failure during pivotal GLP preclinical studies can be minimized. These studies early feasibility studies help sponsors make informed decisions about the next steps in the development and testing process.
Compared to GLP studies, non-GLP studies receive less regulatory scrutiny and have lower archive and report standard requirements, making them more cost-effective. Additionally, non-GLP studies can be scheduled and carried out more quickly due to shorter testing durations, smaller sample sizes and faster report delivery. If both non-GLP and GLP studies are completed with NAMSA, pricing and timelines can be optimized. Even though non-GLP studies do not have the same regulatory requirements as GLP studies, NAMSA maintains a high level of quality and accountability. The same state-of-the-art equipment is utilized for both GLP and non-GLP studies. Our team can help you decide between GLP and non-GLP studies and provide the necessary data for the next step in the development process. Contact NAMSA today to discuss your goals with our team.
+1 419.666.9455 (outside of USA)
Reserve your complimentary consultation to learn how NAMSA can help you accelerate your development efforts. Fill out the form below and we'll be in touch shortly.
Additional Resources
-
Video: NAMSA Histology Laboratory
-
Webinar: Pathology Assessment of Medical Devices: Understanding the Basics
-
White Paper: NAMSA Preclinical Research: Recommendations for the Evaluation of Investigational Heart Valve Technologies
-
Webinar: Strategies for Selecting the Right In Vivo Models for Regulated Preclinical Studies
