Areas of Services

Regulatory Pathway Assessment & Strategic Planning

FDA expectations are evolving, and choosing the right regulatory pathway early is one of the most critical decisions teams make. We help you identify the most efficient, evidence-based strategy tailored to your product, risk profile, and development stage.

What We Provide:

  • Assessment of applicable pathway (510(k), de novo, PMA, CLIA/CDx considerations, AI/ML or SaMD classification)

  • Roadmaps aligned with both scientific evidence needs and regulatory expectations

  • Risk-based gap assessments for analytical, clinical, and performance evidence

  • Strategic recommendations to reduce uncertainty and accelerate timelines

  • Competitive and precedent landscape review to support decision-making

Outcome for You:

A clear, defendable regulatory plan that aligns development with FDA expectations and positions your product for successful review.

FDA Meeting Preparation, Submission Planning & Review Support

We help you communicate with FDA effectively, concisely, and strategically — ensuring your questions are framed clearly, your data are well-positioned, and your team is fully prepared for productive interactions.

What We Provide:

  • Q-Sub meeting strategy and planning

  • Drafting and reviewing Q-Sub briefing packages

  • Preparation for FDA meetings, including mock Q&A

  • Submission structure planning and technical strategy

  • Support during interactive review and response cycles

  • Guidance on statistical, methodological, and clinical considerations

Outcome for You:

Stronger FDA interactions, clearer communication, and submissions that anticipate reviewer expectations.

Companion Diagnostics Strategy & Co-Development Guidance

CDx development requires careful coordination between therapeutic and diagnostic programs. With extensive experience in biomarker evaluation and diagnostic regulatory policy, we help teams anticipate scientific and regulatory challenges early.

What We Provide:

  • Early-phase CDx feasibility and regulatory pathway assessment

  • Alignment of biomarker strategy with therapeutic goals

  • Analytical and clinical validation strategy

  • MRCT (multi-regional clinical trial) considerations for biomarker evidence

  • Coordination between pharmaceutical sponsors and diagnostic partners

  • Guidance on global regulatory alignment (FDA, IVDR, select ex-US markets)

Outcome for You:

A coherent, aligned CDx strategy that supports therapeutic development while meeting regulatory expectations.

AI/ML & Digital Health Regulatory Support

Regulation of AI/ML and digital health is rapidly evolving. We help innovators interpret policy, structure evidence, and prepare for regulatory expectations around transparency, performance, and lifecycle management.

What We Provide:

  • SaMD regulatory classification and risk assessment

  • Guidance on Good Machine Learning Practice (GMLP) principles

  • Algorithm change-management frameworks and documentation expectations

  • Performance characterization strategies (analytical, clinical, and real-world)

  • Transparency and explainability considerations

  • Review of labeling, user instructions, and model communication

Outcome for You:

Confidence that your AI/ML or digital health product aligns with current FDA thinking and is positioned for successful review.

Evidence Evaluation & Scientific Advisory

Strong evidence is the foundation of regulatory success. We bring experience reviewing hundreds of devices and diagnostics to help teams critically evaluate their analytical, clinical, and statistical strategies.

What We Provide:

  • Scientific and methodological reviews

  • Evidence gap assessments

  • Evaluation of study design, endpoints, and performance claims

  • Statistical considerations and sample size adequacy

  • Risk–benefit interpretation and justification strategies

  • Recommendations based on real-world reviewer expectations

Outcome for You:

More robust evidence packages that stand up to regulatory scrutiny.

Regulatory Risk Assessment for Investors & Boards

Regulatory risk can significantly influence investment decisions. We provide independent, FDA-informed assessments for investors, boards, and corporate due diligence teams.

What We Provide:

  • Regulatory landscape and risk profile evaluation

  • Assessment of evidence maturity and pathway feasibility

  • Review of regulatory commitments and timelines

  • Evaluation of diagnostic–therapeutic alignment for CDx assets

  • Independent expert perspective for strategic decisions

Outcome for You:

Greater clarity and reduced uncertainty for investment or acquisition decisions.

Let’s Build a Successful Pathway Forward

Regulatory success depends on experience, clarity, and thoughtful planning. The YDX Group offers strategic guidance grounded in deep FDA expertise and real-world understanding of product development challenges.

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