We help our clients meet FDA requirements while meeting their business needs. We support our clients with regulatory consulting, expert witness services, and medtech investor services.
Steve Silverman, President, The Silverman Group
Steve served FDA in leadership positions across the Agency. He adds private-sector expertise from consulting and representing industry members. Steve develops strategies that satisfy regulators and promote business needs.
Medical Product Regulatory Consulting
The Silverman Group helps clients navigate regulatory challenges as they build and leverage relationships with regulators to achieve business goals.
Expert Witness
Services
Drawing on Steve Silverman's senior FDA leadership experience, we help attorneys handling FDA matters explain regulatory requirements to judges, juries, and other attorneys.
MedTech Investor
Services
We help MedTech investors map the regulatory landscape, including costs, derailers, and timelines affecting their portfolios. These services are shaped by Steve Silverman’s unique experience as a senior FDA leader and a consultant to medical product companies.
Publications
Our media activities include articles, webinars, and podcasts on core and new MedTech topics.
