
Regulatory-Grade Quality Control for the Life Sciences
QC + Regulatory support for MedTech, Biotech, and AI-driven health startups.
Regulatory Document Review
CoA, IFU, and labeling audits for FDA, ISO, and EU MDR compliance.
NLP-Powered QC
Hybrid AI + human review of literature reviews, postmarket surveillance docs, and AI training datasets.
QMS & Process Consulting
SOP creation, validation plan writing, and inspection readiness prep for small teams and startups.
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