Supporting regulated medical products from proof-of-concept to commercialization

Streamlining integration of regulatory strategy with global business development for medical devices, diagnostics, biologics and pharmaceuticals.

Support at all stages

Applying decades of experience navigating regulatory requirements to securing approvals, establishing compliant operations, and supporting successful marketing of medical devices, biologics, pharmaceuticals and in vitro diagnostics worldwide.

Regulatory strategy development

Specialized expertise in accelerated approval pathways, hands-on experience with all product types and classes, and establishing a positive relationship with governing bodies.

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Tailored support for startups

Combining passion with proven success in helping startups and spinouts navigate the unique challenges of early-stage tech transfer, secure further funding, and avoid costly delays by integrating regulatory compliance into the product development process.

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Market entry and life cycle support

Helping you manage critical milestones in clinical trials, navigate labeling and ad comm, and integrate risk management into the product design cycle from prototype to post-market.

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Interim leadership and executive partnership

Flexible cross-functional support in regulatory affairs, quality assurance, project management, executive training and implementation, as well as outsourced assistance for bioinformatics and data analytics framework development.

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Compliance expertise for scaling companies

Executive leadership experience in quality and compliance across non-profits, startups, and global organizations.

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Change management and global expansion

Helping companies stay ahead of change in the dynamic regulatory landscape in the US, EU, and UK, respond to new requirements, and create harmonized regulatory plans to accelerate global market expansion.

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