Biodextris
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.
To accelerate our growth and drive innovation, we have partnered since 2024 with ARCHIMED, a leading investment firm dedicated to healthcare industries.
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
- Sample Management
- Deviation Management
- Calibration And Preventative Maintenance
- Change Control
- Document Control
- Incident Management
- Risk Management Process
- Training Management
- Organizational Roles And Responsibilities
Data Management System
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.
- Laboratory Notebooks
- Standard Operating Procedures (SOPS)
- Process History Files
- Analytical History Files
- Data Recording Forms
- Stability Reports
