About the Harvard-MIT Center for Regulatory Science

What is regulatory science?
Regulatory science comprises a range of scientific disciplines that are applied to the quality, safety and efficacy assessment of medicinal products and that inform regulatory decision-making throughout the lifecycle of a medicine.

The Harvard-MIT Center for Regulatory Science was formally launched in 2018 to advance research and education in regulatory science. The Center serves the broad community of biomedical research scientists and physicians in academia, industry, and regulatory agencies who seek to improve the development and evaluation of medical products. The Center is open to faculty and trainees from all institutions in the Boston area and aims to establish a three-way dialogue between academic medical research, drug development in biotechnology and pharmaceutical companies, and clinical care in the US and worldwide.

The Center supports a Regulatory Science Fellowship, local and international conferences, and a portfolio of research collaborations with regulatory agencies, industry, and other academic institutions.


We support researchers conducting projects in regulatory science and facilitate cross-disciplinary collaborations between academic groups, biotechnology and pharmaceutical companies, and regulatory agencies.

Learn more about our research here


We are training the next generation of regulatory science researchers through a dedicated fellowship program, formal educational events, internships, and mentored collaborations.

Learn more about our educational programs here


As part of our mission we serve as convener of diverse stakeholders to tackle large, systematic problems in the development, delivery, and use of new therapeutics through annual symposia, topic-focused workshops, and working groups.


Harvard, MIT, and the FDA have partnered to create a center focused on innovative approaches for the development and evaluation of medical products. Together, we engage with partners in regional academic institutions, biotechnology and pharmaceutical companies, regulatory agencies, patient advocacy groups and other nonprofit organizations.

If you are interested in learning more or collaborating, you can reach out to us at hits_regsci@hms.harvard.edu.