Andrew Hillman advises founders, investors, and operators in FDA-regulated healthcare and frontier biotech. The advisory practice brings operator judgment to the decisions that most often determine whether a healthcare company succeeds or stalls.
What the advisory covers
- FDA regulatory strategy. Choosing and sequencing the right pathway, from the IND through approval, including the 351(a) biologics route and expedited programs.
- FDA commercialization. Turning a cleared product into a business, with attention to evidence, labeling, and market entry.
- Biotech investment diligence. Operator-level evaluation of science, manufacturing, and the path to patients.
- Ambulatory surgery center and healthcare operations. Practical guidance drawn from owning and running these businesses.
The basis of the work
The advisory rests on three decades building, operating, and exiting FDA-regulated healthcare companies across hospitals, ambulatory surgery centers, clinical laboratories, pharmacy, and medical devices. That record means the advice is grounded in having done the work, not only studied it. The reasoning behind it is shared openly in the featured insights, including why manufacturing is the real moat.
Who it is for
Founders preparing for a regulatory milestone, investors evaluating a healthcare or biotech opportunity, and operators facing a commercialization or compliance question. Engagements are scoped to the client's stage and need.
Learn more
The dedicated advisory site is at andrewhillmanadvisor.com. For litigation support specifically, see the expert witness profile.
Discuss an advisory engagement.
Visit the advisory practiceFrequently asked questions
What advisory does Andrew Hillman provide?
Strategic advisory covering FDA regulatory strategy, FDA commercialization, biotech investment diligence, and ambulatory surgery center and healthcare operations.
Who is the advisory for?
Founders preparing for a regulatory milestone, investors evaluating a healthcare or biotech opportunity, and operators facing a commercialization or compliance question.