GXP Consulting directed by hands-on experience
Mitigating your GXP risks through the application of proven Science and Compliance - based strategies
Our Experience
Extensive hands-on experience in the complete life cycle for Biotech and Small Molecule Drugs, from R&D through clinical development and successful global commercialization. Leadership for small and large Quality Departments, responsible for GXP Quality Systems, QA/QC operations, QMS, SOPs and internal/external manufacturing, GXP oversight and training. Clinical Cell and Gene Therapy Quality, methods, and troubleshooting. High-level decontamination of isolators/areas. Continuous improvements using Lean - Six Sigma tools.
Why Us?
A verified track-record of meaningful accomplishments in the small, medium and Big Pharma/Biotech/ATMP settings
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