Pharmaceuticals
cGMP under 21 CFR 210/211, EU GMP, and ICH Q10.
Photo: National Cancer Institute / Unsplash
Industries
GxP is bigger than pharma.
If you keep controlled documents, investigate deviations, and host inspectors, you are in the neighbourhood.
Biotechnology
Cell, gene, and vaccine programs with a clean validation story.
Photo: National Cancer Institute / Unsplash
Medical devices
ISO 13485, FDA QMSR, and EU MDR — design to post-market.
Photo: Martha Dominguez de Gouveia / Unsplash
Diagnostics & IVD
Assay, instrument, and software-as-IVD quality in one system.
Photo: Online Marketing / Unsplash
CDMO & CMO
Multi-product sites, client quality agreements, batch control.
Photo: ThisisEngineering / Unsplash
Contract research
GCP document control and training sponsors can inspect.
Photo: National Cancer Institute / Unsplash
Specialty chemicals
ISO 9001, COA, and process change control.
Photo: National Cancer Institute / Unsplash
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45 minutes
See it on your processes.
Forty-five minutes. Bring an SOP, a deviation, or a validation gap.
Book a demo