Regulatory Strategy & FDA Engagement

What's typically included

• Pathway analysis & regulatory positioning — evaluating the regulatory routes available for a product, the trade-offs between them, and the strategic implications of each.
• Product classification — resolving classification questions (drug, device, supplement, cosmetic, combination) where the answer shapes everything downstream.
• Development-stage gap assessments — identifying where the development plan, evidence package, or regulatory record falls short of what the chosen pathway will require.
• Lifecycle strategy — planning the regulatory arc from first approval through line extensions, label updates, and post-market commitments.
• FDA meeting strategy — meeting type selection, briefing strategy, focused question development, internal preparation, and interpretation of FDA feedback.

When this is the right conversation

Companies typically engage RGM here when they are preparing for a Pre-IND, Type B, Type C, or pre-submission meeting; when a product's classification is contested or ambiguous; when an existing pathway plan needs an outside read before commitment; or when FDA feedback has landed and the team needs to decide what it actually means for the program.

Output you can use

A clear position on the pathway. A briefing package or briefing-strategy document that the internal team and the FDA can both work with. A short, decision-ready read on what the agency is most likely to push back on, and what to do about it. Recommendations that can be brought to a board, an investor, or a development committee without further translation.