CMC Quality offers consulting and project support within the following areas:
CMC Documentation
Authoring, reviewing, and harmonizing CMC sections for regulatory submissions (Module 3)
Support for development reports, manufacturing descriptions, and analytical methods
Quality Assurance
Establishing, optimizing, and maintaining Quality Management Systems (QMS)
Deviation handling, SOP, OOS, Change controls, risk assessments and continuous improvement
Regulatory Support
Guidance on CMC-related regulatory strategy and document readiness for EMA and FDA submissions
Analytical development & validation
Development of chromatographic methods. Validation of analytical methods