How do Exponent's multidisciplinary teams help you navigate complex global regulatory frameworks?
Whether adapting to new regulatory frameworks or entering new therapeutic areas, manufacturers are continually challenged with meeting new or evolving regulatory requirements for bringing innovative products to market.
Exponent provides extensive expertise in U.S. and international pharmaceutical, medical device, and combination product regulations (including those that impact software-based digital products) to help you overcome regulatory challenges for a range of applications and needs, such as in vitro diagnostics, and biotechnology product development.
Life science companies count on Exponent's decades of experience and objective, science-backed analyses and insights to navigate regulatory complexities in terms of regulatory strategy, health authority engagement, preclinical testing, clinical strategies, manufacturing support, and submission preparation in order to help enable a more informed and streamlined path to commercialization.
Our regulatory compliance services provide a range of support for products at the forefront of life sciences.
Our Capabilities Are Unparalleled
With expertise in over 90 disciplines and hundreds of capabilities, tools, and methodologies — we get to the root of even the most complex challenges and give you the objective answers you need.
Life Sciences Due Diligence
Due diligence technical consulting services to help verify the science and technology behind medical devices and related therapeutics.
Medical Device Evaluation
Sophisticated medical device evaluations for a vast array of applications.
Medical Device Design & Development Support
Crucial medical device design and development analyses to empower your decision-making.
Biomedical Expertise for Therapeutic Areas
Multidisciplinary insights for a range of therapeutic product development challenges.
Biomedical Engineering Laboratories
Expert biomedical laboratory services, delivering evidence-based answers for your most complex challenges.
Biomedical Expertise for Disputes
Support for complex disputes, from intellectual property and patent infringement to hospital fires and product damage.
Our global and comprehensive expertise across industries gives us a deep understanding of current challenges, best industry practices, and the implications of emerging technologies.
Practice Director and Principal Scientist
Office Director and Principal
Senior Managing Scientist