Sigma Biotech integrates research, regulatory, quality, and clinical strategy to accelerate biomedical innovation from concept to patient impact.
Note: All content and engagements are subject to Sigma’s internal quality and regulatory review.
Integrated Expertise
20+
Years Experience
Global
Regulatory Reach
End-to-End
Lifecycle Support
Integrated
One-Firm Model
Translational research bridges the gap between discovery and real patient impact. It takes promising science and shapes it into something that can be safely tested, validated, approved, and used in clinical practice.
Sigma simplifies complex decisions by aligning evidence needs, regulatory expectations, clinical feasibility, and operational efficiency — early, not late.
What we simplify
Leadership experience includes supporting a fastest-enrolling clinical study leading to subsequent PMA approval — demonstrating rigorous strategy aligned with execution.
Co-development of the clinically validated SPOT GRADE bleeding severity scale — supporting consistent clinical assessment and evidence quality.
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.
Regulatory, clinical, quality, and end-user needs considered from day one.
An extension of your internal team — not a vendor.
Integrated capabilities designed to support innovation across the full development lifecycle.
Align science, regulation, and clinical execution.
Strategic submissions and quality systems.
Protocol design, operations, and evidence generation.
Cross-Disciplinary Focus
Bring clarity, structure, and translational rigor to your development program.