Our Expertise

Regulatory strategy

We understand how drug, device, and biologic requirements overlap in the US, Europe, and beyond. We’ll help you define where your product stands in the regulatory landscape.

Clinical research

Our team of experts has decades of experience in providing guidance on clinical evidence collection requirements, designing respective activities, and conducting medical device clinical studies to European requirements.

Human factors research & design

Put a safer, more competitive device in the hands of patients and healthcare providers. Our human factors experts have deep expertise in medical device design.

Related News and Resources

The latest industry insights from our global team.

Regulatory Updates
Chinese regulators revise drug-device combination product registration requirements

Thu Aug 26
Regulatory Updates
Electronic medical records design: Five things I love about you

Tue Aug 24
Regulatory Updates
European regulatory roundup: Combination products, MDR clinical investigations, COVID-19 IVD performance evaluations

Tue Aug 17
Regulatory Updates
The future of SOP compliance for life science companies

Wed Jul 28