From local CDMO to global expansion
Who is Biodextris?
Biodextris is comprised of experienced product development scientists located in Laval (Montreal), Quebec. The Biodextris Team has worked together in mid and large sized vaccine companies for the past 18 years, now offering our big pharma expertise in a more personal and interactive package. We develop, manufacture and test a wide range of biologic products for vaccine, pharmaceutical and other applications. Your projects is overseen by dedicated project managers with extensive hands-on experience, saving you time and enhancing your experience.
We have developed numerous products for all phases of clinical development for programs conducted in the US, Canada and Europe. Our history leaves us with the know-how for high quality, robust, commercial product development combined with flexibility and the sense of urgency inherent in smaller organizations.
THE WAY A CDMO SHOULD BE
With Biodextris, your project is overseen by dedicated project managers with extensive hands-on experience, saving you time and enhancing your experience. We offer technical and quality guidance, with cGMP compliant testing to ensure you successfully navigate the regulatory path for your product.
Quality Management System
We offer technical and quality expertise, ensuring cGMP compliant testing is conducted, supporting you in navigating the regulatory path for your product. Built upon years of experience, our Quality System is optimized to meet technical and regulatory requirements in an efficient manner.
Quality policies and Quality Manual
Standard Operating Procedures (SOP’s)
Validation Master Plan
Calibration and Preventative maintenance
Risk management process
Organizational roles and responsibilities
We manage process and product knowledge throughout development.
Our information systems safely store your data and comply with requirements of regulatory and intellectual property agencies.