Who Are We?

We advise early engagement. Avoiding problems is far more efficient than fixing them — but when fixing is what's needed, we're the team that gets it done.

RSP works where others get stuck. With 30+ years of unmatched FDA expertise — including senior leadership of the agency itself — we identify the fastest, most efficient path to approval. In today's unpredictable regulatory environment, that expertise is not a luxury. It is essential.

"Even in today's uncertain world, we create streamlined pathways to approval — saving clients years of development time and millions of dollars."

Rachel E. Sherman, MD, MPH, FACP, Founder,  Rachel Sherman Partners, LLC

The Ways We Work — One Standard of Excellence

Early partnership: The best outcomes start before problems arise. We can integrate with your team from the earliest stages of development — shaping study design, regulatory strategy, and FDA interactions so that obstacles never materialize in the first place.

Crisis rescue: When a clinical hold, RTF, failed advisory committee, or CRL stalls a program, CEOs and boards of directors call RSP. We step in, cut through the noise, and deliver results — fast. We solve the problems that stump others.

Client Wins

Since founding RSP in 2019, Dr. Rachel Sherman and her network have delivered concrete, measurable and highly positive outcomes:

💊 $2B+ Asset Sale — Rare Disease Drug

After a 10-year regulatory history including two CRLs and a refuse-to-file decision, RSP guided the client to a successful FDA submission. The asset was then sold for over $2 billion.

💰 Identified the Right Data Pathway

RSP discovered a client had been incorrectly advised to conduct a full preclinical PK work-up. RSP redirected to the 505(b)(2) pathway — requiring only human PK data — saving millions in unnecessary studies and up to a year of development time.

💰 Eliminated an Unnecessary RCT

A client was preparing to launch a costly randomized controlled trial for biosimilar approval. RSP identified that an RCT was not required — saving millions of dollars and years of development.

✅ FDA Approval After Rejection

RSP secured FDA approval for a rare, typically fatal disease — despite a prior CRL, an unethical RCT demand, and a strongly negative FDA position. Drawing on decades of experience running advisory committees, RSP ensured that the client presented the critical data and cited the seminal regulatory documents — developing an offense, not a defense. The result was not, as expected, a negative outcome but a positive one.

⚡ Clinical Holds Resolved in Days

Multiple biotech clients have turned to RSP after months of stalled trials and burned capital. Where others had failed, RSP's forceful, cogent arguments resolved holds within days to weeks of engaging FDA.

🏛️ FDA's Rare Disease Innovation Hub

Dr. Sherman spearheaded the public-private partnership launched in July 2024 that culminated in establishing the FDA Rare Disease Innovation Hub — one of many landmark policy achievements spanning her career at FDA and beyond.

🧬 Four Gene Therapy Approvals in Under a Year

RSP formed and led a consortium whose white paper on accelerated approval and gene therapy led to four FDA approvals within less than a year of publication.

📋 CEO Coaching & Leadership Restructuring

Engaged by a board of directors to coach the CEO, restructure the executive office, and fill critical leadership gaps,  RSP positioned the client company to complete its stalled development programs and successfully submit an IND.

📈 Multi-Million Dollar VC & PE Due Diligence Gains

RSP's regulatory due diligence on early-stage companies and drug assets has consistently maximized ROI and prevented costly missteps for venture capital and private equity investors.

Whether you need a long-term strategic partner or a second opinion on a single pressing issue — we are here to support you.