Technical Due Diligence and Regulatory Support
Regulatory, Biocompatibility, Biostability, Toxicology Risk Assessment, and Quality Management Systems
Expertise in Biomaterials, Biologics, and Medical Device Development
The regulatory landscape for medical devices, biomaterials, and biologics is rapidly changing and our expert advisory services can shorten your path from idea, design freeze, regulatory approval to commercialization. We assist in all aspects of scientific and technical due diligence to devise your biological risk assessment plan and guide you through the regulatory pathway. Contact us today for a free quote.
Why choose us
We assist clients in getting through the regulatory hurdles with the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) and can provide assistance in Biocompatibility, Biostability, Toxicology Risk Assessment, and Quality Management Systems.