Sigma Biotech supports complex biomedical technologies across indications where translational alignment, regulatory strategy, and evidence generation are critical to success.
From early feasibility through post-market surveillance, we support device programs requiring rigorous translational and regulatory alignment.
Diagnostic technologies demand early integration of clinical utility, regulatory classification, and validation strategy.
AI-enabled technologies require clear translational intent, regulatory awareness, and lifecycle governance.
Combination products demand coordination across regulatory, quality, and clinical domains from the outset.
We guide sponsor teams in selecting, managing, and governing CRO relationships effectively.
Post-market evidence is increasingly central to regulatory, clinical, and commercial success.
Most programs span multiple domains. We help define the right strategy regardless of indication or modality.