Who is Biodextris?
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
Sample management
Deviation management
Calibration and Preventative maintenance
Change Control
Document Control
Incident management
Risk management process
Training management
Organizational roles and responsibilities
Knowledge Management
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
Meet our Management Team
Companies can rely on the Biodextris Team to deliver excellent services for a wide range of biologic products. 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.
From Analytical Development to Quality Management, our team of experienced product development scientists will get you through your project.
Joseph Zimmermann
President and CEO
Christine Jacques
Director Analytical Services
Paul Rice
Director Process Services