Data Regulators Can Trust

Streamlined Testing

At SizeID.bio, your dataset becomes your dossier.

With ISO-certified workflows, FDA-facing experience, and 10,000+ particles measured in a single run, we deliver regulator-ready evidence for fewer questions and faster ANDA approvals.

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nasal spray particles on a surface individually identified and measured by means of morphology directed raman spectroscopy

Why Choose SizeID.bio?

Why Choose SizeID.bio?

MDRS reinvented with the maximum sensitivity and deepmorph.AI

Regulators demand robust, reproducible in-vitro evidence. But most MDRS workflows still struggle with speed and statistical depth.

🔹 Competitors

  • ~3,000 particles per run in 12 hours

  • Limited statistical confidence

  • External QC needed to monitor signal/noise

🔹 SizeID.bio

  • 10,000+ drug-specific particles and agglomerates in a single run

  • Completed in just 6 hours, not overnight

  • Internal signal/noise control — fully USP <858> compliant

  • ISO 9001 laboratory, validated SOPs, FDA-facing experience

Here’s what sets us apart:

Faster results.
More particles measured — much faster. Complete datasets in hours, not days.

Fewer regulatory questions.
Reports written in the format FDA and EMA reviewers expect — clear, consistent, and statistically solid.

No blind spots.
Particles below 1 µm, fully resolved — delivering the complete picture many labs miss.

Reliable data, every time.
All work performed under ISO 9001 standards with built-in quality checks for accuracy and signal integrity.

Straightforward reporting.
Results you can drop straight into your submission — no extra interpretation needed.

In short: clearer data, faster studies, and fewer surprises — so your OINDP projects reach patients sooner.