About Us
Technical Experience
TurnAround time and budget focused
TurnAround time and budget focused
Over a decade of Biocompatibility and Toxicology experience both at an industry leading CRO as well as within Medial Device Manufacturing industry. Previous GLP Study Director management experience across a wide range of medical device sub-specialties including but not limited to: orthopedics, cardiovascular intervention devices, wound healing devices, combination devices, hemodialysis, etc.
TurnAround time and budget focused
TurnAround time and budget focused
TurnAround time and budget focused
We strive to deliver industry leading Biological Evaluation Plans, Biological Safety Evaluations and Toxicological Risk Assessments. With years of industry experience, we know the client's timeline is of upmost importance and leverage our small business model to ensure the flexibility and timing of our deliverables to maintain clients' timeline and budget.
regulatory experience
TurnAround time and budget focused
regulatory experience
Experience in Biological and Toxicological Risk Assessments submitted/accepted to numerous regulatory agencies including US FDA, EU MDR Notified Bodies, NMPA (China), and Germany. Additionally, we have experience with material change assessments, biological gap assessments, PROP 65/EU REACH/RoHS/MDR material compliance reviews, equivalency assessments and technical memorandums for acute/contained manufacturing issues that arise.