Quality is our #1 priority in everything we do
Through our Quality, Regulatory and Clinical Services we support our customers in establishing their own quality standards and operate accordingly. We work with our customers on the regulatory submissions, and help them complete testing requirements, be that on the bench top, in vivo, or in the clinic.
Services
Quality Services
Regulatory Services
Clinical Services
Quality services
Our quality team is an active member of the development team, which ensures that both project and product documentation is prepared in tandem with product development and manufacturing implementation. We can carry development program under our own quality system or work under yours. We are proficient in ISO 13485 quality system development, which we offer to our start up company customers.
Regulatory services
We create and compile documentation for regulatory submissions and support your complete regulatory application processes in the US or in the EU. We have valuable relationships with GLP certified laboratories for pre-clinical testing, academic and clinical institutions for tissue, in vivo and clinical testing, US regulatory bodies and European Notified Bodies.
Clinical services
We have the capabilities and the relationships necessary to organize and conduct first-in-man and clinical trials. We have deeply rooted research partnerships with various clinical and academic centers & clinical experts, which we are eager to bring to bear in support of your project.
