Translational Research Without Silos

Sigma Biotech integrates research, regulatory, quality, and clinical strategy to accelerate biomedical innovation from concept to patient impact.

Integrated Expertise

  • • Translational Strategy
  • • Regulatory & Quality
  • • Clinical Research
  • • Post-Market Evidence

20+

Years Experience

Global

Regulatory Reach

End-to-End

Lifecycle Support

Integrated

One-Firm Model

Why Sigma Biotech

Sigma (∑) represents the summation of all moving parts in biotechnology development.

We reduce redundancy, mitigate downstream risk, and align science with regulatory and commercial reality.

Design With the End in Mind

Regulatory, clinical, quality, and end-user needs considered from day one.

One Integrated Team

An extension of your internal team — not a vendor.

Services

Integrated capabilities designed to support innovation across the full development lifecycle.

Translational Strategy

Align science, regulation, and clinical execution.

Regulatory & Quality

Strategic submissions and quality systems.

Clinical Research

Protocol design, operations, and evidence generation.

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Areas of Expertise

Medical Devices Diagnostics AI / ML Combination Products CRO Strategy Longevity Research

Cross-Disciplinary Focus

  • • Pre-clinical to post-market
  • • Regulatory-aware design
  • • Real-world evidence

Ready to Build Smarter?

Bring clarity, structure, and translational rigor to your development program.