6 Cabot Place, Suite 5 Stoughton, MA 02072
(+1)617-213-1600
Driving Success in Life Sciences
Innovative Regulatory Science Solutions for the Life Sciences Industry
Strategic Regulatory Solutions to Achieve Your Corporate Goals
Our team of seasoned consultants brings extensive experience across the life sciences industry, including small biotech startups and global pharmaceutical leaders, delivering tailored expertise to meet diverse needs.
Regulatory and Quality Support Services
Regulatory Strategy Services
Clinical Site Monitoring Services
Manufacturing and Testing
Gap Analysis and Building your Regulatory Story
Regulatory Services
Provide regulatory needs to move the development of your programs.
Regulatory Submissions
Maintenance of regulatory documents and administrative tracking
Regulatory support for safety data review, processing and submission
Coordinate and document regulatory meetings
Your Comprehensive Partner for Life Science Solutions
From regulatory compliance and clinical trial support to strategic consulting and innovative technology, we provide everything you need to drive success in the life sciences industry—all in one place.
Clinical Site Management
At IRSG, we offer comprehensive Site Management Organization (SMO) services to streamline and optimize clinical trials. Our services include site identification and selection, study start-up support, continuous site monitoring, patient recruitment strategies, and regulatory compliance oversight. Leveraging our extensive network of research sites and innovative project management technology, we ensure high-quality, efficient, and compliant trial operations. Partner with us to simplify the complexities of clinical trial site management and drive your studies to success.
Our Team
At IRSG, our foundation is anchored in Boston, Massachusetts, a global hub for cutting-edge drug development. From this strategic location, we’ve cultivated partnerships across the West Coast, Europe, Asia, and around the globe. These collaborations are built one project at a time, driven by our commitment to exceptional client service, deep regulatory expertise, and a flexible suite of solutions designed to adapt to your unique needs.
Whether you’re preparing for a regulatory submission, launching a clinical trial, finalizing a licensing agreement, or seeking product approval, IRSG delivers specialized teams with the expertise to guide you at every step. With decades of experience, we are prepared to navigate complex challenges and leverage our insight into industry and regulatory trends to ensure a streamlined path to success.
Whether you’re preparing for a regulatory submission, launching a clinical trial, finalizing a licensing agreement, or seeking product approval, IRSG delivers specialized teams with the expertise to guide you at every step. With decades of experience, we are prepared to navigate complex challenges and leverage our insight into industry and regulatory trends to ensure a streamlined path to success.
Founder and Principal ConsultantDr. Leona Saunders
Office ManagerElizabeth Banks
Business Development ManagerTye Saunders
