Who is actually doing your work?

Founders: when you hire a regulatory consulting firm, are you actually getting a regulatory team, or are you paying the firm to give you access to one consultant?

I’ve worked under both models: as a consultant hired through another regulatory consulting firm, and through my own independent practice.

In some projects I supported through a consulting firm, I was the only regulatory consultant working directly on the client’s project. I developed the strategy, prepared the deliverables, worked with the client, and supported FDA interactions.

Through an independent practice, a client may get that same direct expertise through a leaner structure and at a lower overall cost.

For an early-stage startup, that can mean direct access to the person doing the work, continuity from strategy through execution, and fewer layers between the founder and the regulatory decision-maker.

Of course, a firm can make sense when a project genuinely requires multiple specialists or significant additional bandwidth.

So before hiring a regulatory consulting firm, ask:

Who is actually doing my work?

And yes, for anyone looking closely, that’s me on both sides. 😄