Our Mission

Help innovators bring products to market. Clients rely on our expertise and 30+ years of experience in In Vitro Diagnostics (IVDs) and Medical Devices to navigate customer and regulatory requirements and accelerate the time from product idea to routine clinical use.

Our Services

Regulatory Affairs/CRO Services

Quality Systems Compliance

Point-of-Care Analyzer Training

Who We Serve


We provide insights on product concepts, build your quality system, develop a tailored regulatory strategy and accelerate your path to achieving your first approval.


We add our expertise to your team to ensure compliance of existing QMS, expand your approved product portfolio and support your commercial efforts.


We add our expertise to areas where there may be gaps in your existing organization to drive projects forward and meet corporate objectives.

Let's Talk