Expert Partner

Preparing regulatory submissions for medical devices is a team marathon.
Let us run a lap or two for you.

Regulatory Affairs

You choose the pathway and set the milestones.
We share the workload to help you finish strong.

Systematic Literature Review

Robust, systematic literature reviews are key components of regulatory submissions. We run these races every day. Our processes are comprehensive, traceable, and reproducible every step of the way.

Adverse Event Database Reviews

We design, execute, and adjudicate customized searches of international databases to provide you with high quality safety data. This allows for Real World experience to inform the development of your device.

Data Mining for Statistical Analysis

We systematically mine and collate data from the scientific literature data, providing you with a statistician-ready dataset for analysis. This speeds your progress to study endpoint, performance goal, and OPC (objective performance criteria) development.

From De Novo to Legacy

Whether your project is a novel concept or a well-established brand, we provide the support you need to secure your place in the market.  We bring clinical expertise and scientific rigor to every stage of the product life cycle

Your vision. Your team. Our support.

Our clients range from medtech startups to industry giants. We bring our experienced regulatory and clinical perspectives to your projects, adding to the talents of your team.