Drug development continues to become more complex. Advances in gene and cell therapies, new service capabilities, big data and even changes to the way drug developers use statistical approaches are driving the growing complexity of designing and executing clinical trials. As drug developers utilize these cutting-edge approaches, it is important to effectively interpret global regulatory agencies’ guidance’s to establish the most efficient drug development pathway towards approval.
To support our Sponsors in navigating these complexities and to provide clarity on the best diverse regulatory approaches across multiple therapeutic areas, we have initiated a partnership with Greenleaf Health, a leading FDA regulatory consulting firm based in Washington DC. Comprised of experts with a combined total of more than 300 years of FDA experience, Greenleaf’s comprehensive services and wealth of experience can help us to deliver regulatory strategies for Sponsors through the lens of the FDA.
“The experience and perspectives gained from the experts at Greenleaf Health will be invaluable in accelerating clinical development, particularly in complex areas such as advanced therapies,” notes Jon Isaacsohn, MD, FACC, Executive Vice President at Medpace. “This partnership strengthens our global Regulatory Affairs offering and allows us to expand our strategic capabilities to support our Sponsors’ programs.”
This partnership will allow us to more effectively provide the following services to our Sponsors:
- Strategic and technical guidance for medical product development and regulatory review
- Compliance assessments, remediation, and inspection readiness
- FDA meeting preparation and communication
- Advisory services
- Medical product labeling and promotion
- Regulatory policy consultation, strategic planning, and communications
- Regulatory benchmarking
Learn more about Medpace’s global regulatory affairs capabilities here.