Overview

From discovery candidates to clinical trial materials, BioDuro’s analytical team provides the necessary data needed throughout the development process.  BioDuro’s cGMP analytical laboratories facilitate integrated and efficient project support with analytical scientist actively engaging with clients and providing analyses to Formulations and Manufacturing departments. Equipped with state-of-the-art instruments, BioDuro’s experienced analytical team ensures quality services through Phase III studies.

The BioDuro Advantage

• Strict adherence to ICH and cGMP guidelines
• Continuity in analytical work – training and transfer of analytical methods to Quality Control
• Engagement in project management throughout the development process
• Development of robust and easily transferrable methods

Services

Our analytical team provides a broad range of services including:

• Method evaluation/transfer
• Method development
• Method qualification/validation
• Raw materials testing
• Product-specification support
• In-process prototype testing
• Stability studies
• Finished product release testing
• ICH stability testing

Capabilities

Our laboratories host state-of-the-art instruments enabling the following:

• Chromatography
  • HPLC with UV/Vis, CAD, PDA and Fluorescence detection
  • GC with Headspace Analysis
• Spectroscopy (FTIR, UV)
• Dissolution and Disintegration Testing
• Karl Fischer
• Physical Testing
• Particle Analysis
• Thermal Analysis
• Microscopy