Explore Our Services

We operate as a specialized consultancy, tapping into a curated team of senior experts, including former regulator and industry leaders, tailored to the specific technical and regulatory needs of each project. We provide high-impact human factors engineering, regulatory strategy, risk management, and fractional leadership within the biopharmaceutical and medical device industries.

What We Offer

Strategic Consulting

Human Factors & Risk Management project-based strategy support tailored to your product lifecycle, process improvements, or QMS integration needs.

  • Total Product Lifecycle Support: Strategic guidance for Human Factors and Risk Management at every stage of development.

  • Regulatory Strategy & Gap Analysis: Proactively identify vulnerabilities or blind spots and build a robust, actionable regulatory pathway.

  • Process Optimization & QMS Integration: Streamline your internal operations and integrate updated processes into your Quality Management System.

Fractional Leadership & SME Support

Embed senior expertise directly into your teams for dedicated, hands-on guidance. We offer highly flexible engagement models designed to give you exactly the support you need, with predictable resource allocation:

  • Direct Collaboration: Work side-by-side with your internal teams to bridge strategy to execution.

  • Ad Hoc (Not-to-Exceed): Responsive, on-demand support for immediate, short-term needs without the commitment of a full-time hire.

  • Reserved Capacity: Consistent, ongoing oversight (e.g., ~8 hours/week) to provide reliable fractional leadership and steady support across your product lifecycle.

Pre-review of Submission Packages

Need a final set of expert eyes on your Human Factors package before you submit? We offer “micro-consulting’”- a 12–16 hour engagement intentionally designed to mimic the actual time an FDA reviewer will initially have to evaluate your data. We provide an independent, realistic stress test for your medical device or combination product HF submission to ensure you make those critical hours count.

  • Perspective: Benefit from our experience on both the industry and regulatory sides of the table.

  • Refinement & Risk Mitigation: We evaluate your compiled HF data for clarity and impact, while proactively identifying potential regulatory risks and areas that may elicit interaction questions.

  • Comprehensive Pathway Support: Tailored feedback to support your specific goal, from early Pre-Subs and IDEs/INDs to final 510(k), De Novo, PMA, NDA, BLA, or ANDA submissions.

Technical Capabilities

Human Factors Engineering & Regulatory Leadership

We specialize in IEC 62366-1 and US FDA HF deliverables. Our differentiator: micro-consulting (a 12–16-hour project) to provide independent review and feedback of an HF documentation package prior to submission, led by a former FDA HF Team Lead. We also offer right-sized ongoing HF SME support for various pathways (De Novo, 510(k), PMA, IND, NDA, BLA, ANDA, etc.) and provide technical mentorship to accelerate internal HF teams.

Integrated Risk Management

We facilitate ISO 14971 Risk Management File (RMF) deliverables, remediation, and safety assurance cases. For combination products, this incorporates ICH Q8/9/10 principles, ensuring risk management and quality are integrated throughout the entire product lifecycle.

Combination Product QMS & GMP

We provide targeted support, at the product or QMS level, to bridge the gap between device regulations (QMSR) and pharmaceutical quality standards (ICH Q8/9/10), to optimize systems for combination product portfolios

Data Rigor & Study Design

We provide SME support to design and defend qualitative and quantitative data strategies. We ensure your methods are scientifically and statistically robust, providing the technical rigor necessary to satisfy customers, stakeholders, and regulators alike.

Get In Touch

If you're interested in working with us, complete the form with a few details about your project. We'll review your message and get back to you within 48 hours.