GXP Consulting directed by hands-on experience
Mitigating your GXP risks and driving improvementthrough 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 API and DP manufacturing QA, GXP oversight and training. Clinical cell and gene therapy QA, analytical methods, and troubleshooting. High-level decontamination of isolators/areas. Continuous improvement initiatives using Kaizen, LSS, and other methodologies and tools. Implementing K-AI-Zen™ AI-Assisted improvement projects
Why Us?
A verified track-record of meaningful accomplishments in the small, medium and big Pharma/Biotech/ATMP settings. Collaborating since 2000 with the FDA, EMA, and MHRA on the definition, interpretation, and implementation of Phase Appropriate GMPs