PE, VC, and other investors are at risk when they misunderstand the MedTech regulatory landscape. Smart investors map this terrain, including the decision points, costs, derailers, and timelines affecting their portfolios.
MedTech Investor Services
The Silverman Group helps investors avoid and mitigate negative risk. It focuses on regulatory factors including key decision points, costs, derailers, and timelines. Areas of expertise include:
Pre-acquisition regulatory intelligence — assessment of premarket requirements and compliance concerns. This includes identifying regulatory risk, possible regulator action, and costs and timelines.
Post-acquisition regulatory intelligence — strategies to meet regulatory requirements, including product quality and adverse event response and reporting. We satisfy regulatory requirements, leverage regulatory intelligence, and optimize business results.
Compliance counseling — We help clients satisfy regulatory requirements from premarket review to postmarket oversight. We deploy fit-for-purpose compliance and quality strategies and effective regulator engagement.
