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

Biodextris services

Development Services

Process Development Services