Quality Management System for Pharmaceutical & Biotech Compliance, without the complexity.

Deviations, CAPA, Change Control, Audits, Complaints and Document Management. One cloud system, in five languages.

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21 CFR Part 11 EMA Annex 11 COFEPRIS GAMP 5 GxP

European company
Data hosted in Frankfurt · GDPR-ready

A deviation is recorded ENESDEFRNL

The product

Made for regulated industries

Existing QMS platforms are built for large enterprises. Hemeralis® is built for small and mid-sized pharmaceutical and biotech companies that need to stay compliant.

Cloud-native. Nothing to install.

Log in from any browser. No software to install, no servers to procure, no IT department required. Your QMS is ready the moment you are.

Built compliant

EMA Annex 11, 21 CFR Part 11, GAMP 5, and COFEPRIS are first-class design requirements — not add-ons bolted on after the fact.

Lightweight & fast

No month-long implementation projects. No army of consultants. Up and running in days, not quarters.

Vendor-operated

We manage deployments, migrations, and upgrades on your behalf. Your team focuses on quality, not on infrastructure.

End-to-end quality workflows

Deviations, Change Control, Audits, CAPA, Complaints and Document Management — all connected, all in one place.

Multilingual by design

English, Spanish, German, French and Dutch are first-class languages throughout the platform — not an afterthought.

Where we are launching

Designed for three markets from day one

Europe

EMA · Annex 11 · GDPR-ready

United States

21 CFR Part 11 · FDA-ready

México

COFEPRIS-ready

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See it running on your own processes

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