Regulatory & Product Strategy / Service

Innovation & Product Development Advisory

Senior input on product concepts, target product profiles, development sequencing, and the trade-offs between scientific ambition, regulatory feasibility, and commercial intent.

Innovation and product development advisory

The Work

Most product development programs are shaped early by assumptions that go unchallenged. A target product profile gets locked in before the regulatory, evidentiary, and commercial implications have been fully reconciled. Development sequencing follows scientific instinct rather than the decisions an evidence package will actually need to support. Innovation portfolios accumulate concepts that each look defensible on their own but compete for the same limited regulatory bandwidth. RGM provides senior input at exactly these moments — while the program is still flexible enough for the input to matter.

The work draws on decades of operating experience leading regulatory and innovation strategy inside global organizations spanning OTC drugs, Rx-to-OTC switch, food supplements, medical devices, and consumer healthcare. The goal is to sharpen the development plan before commitments harden — so that scientific ambition, regulatory feasibility, and commercial intent are pulling in the same direction.

What's typically included

  • Target product profile (TPP) development & review — pressure-testing the proposed product profile against regulatory feasibility, evidence requirements, and commercial positioning before it becomes the spine of the program.
  • Development sequencing — advising on the order and dependency of preclinical, clinical, regulatory, and quality activities so the program generates the evidence it actually needs in the order it needs it.
  • Evidence-requirements mapping — clarifying what evidence the chosen pathway, claims set, and commercial positioning will require, and where the current plan falls short.
  • Trade-off framing — surfacing the live tension between scientific ambition, regulatory feasibility, and commercial intent so leadership can resolve it deliberately rather than by default.
  • Portfolio prioritization — senior read on which concepts to advance, which to reshape, and which to deprioritize, with the regulatory and commercial logic for each call.

When this is the right conversation

Heads of innovation, R&D leaders, and founders typically engage RGM here when a TPP is being drafted or revisited; when a development plan needs an outside read before significant investment; when a portfolio has expanded faster than the organization's capacity to advance it; or when the team is debating which concept deserves the next dollar and the next month of regulatory bandwidth.

Output you can use

A reviewed and sharpened target product profile. A development sequencing recommendation that ties activities to the decisions they need to enable. A portfolio-level read on where to lean in and where to pull back, written so it can go to a board, an investor, or an innovation committee without further translation.

Sharpening a product concept or development plan?

Tell us where the program is and what the team is trying to decide.

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