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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