Rachel Sherman Partners, LLC
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ARE YOU Involved in Medical Product Development?

We Have the Knowledge, Skills, and Strategies You Need to Get Your Products to Patients

 
 

Who Are We?

Rachel Sherman Partners, LLC, provides critical client support on all types of FDA regulatory interactions. We are committed to ensuring that our clients benefit from the modernization of medical product development, based on the latest scientific advances. FDA regulatory structures are changing in an unprecedented and unpredictable manner. As a result, we are guiding clients through what have become uncharted waters. Nevertheless, our key goal remains the same—to help important therapies reach patients as soon as possible.

For each of our clients, we work primarily with CEOs and Board Chairs to identify development and regulatory strategies that give clients the flexibility to advance their therapies as safely and expeditiously as possible. We also provide detailed guidance on the urgent problem of how to optimize interactions with FDA staff. Rachel Sherman Partners has extensive biotech and pharma experience and understands the challenges to developing therapies. We have been increasingly focused on fostering advances in oncology therapies and on the development of treatments for neurodegenerative disorders. No matter the size or type of your life science company, we can identify your best regulatory options.  

We can help with a broad range of questions. For example:

  • Are you facing challenges communicating effectively with FDA? We can help you optimize your interactions with the agency.

  • Is your regulatory submission as good as it can be? Is it straightforward for reviewers to read? We can provide a fresh perspective on content and format.

  • Are you stuck on just one particular issue, and would like our input on that issue? Talk to us.

  • Is your development program struggling with staffing issues or disagreements about how to proceed? We can build successful teams and help overcome organizational challenges.

  • Would your challenge be best addressed in collaboration with others? We’ve done it before, and we can help you build that critical collaboration—bringing together the best and the brightest.

A lifelong public health advocate, Dr. Sherman remains a key player in this area, most recently spearheading a public private partnership launched in July 2024 that resulted in the establishment of the FDA Rare Disease Innovation Hub. With updated, first-hand knowledge of trends in regulatory affairs, she continues to advance strategies that apply real-world evidence to support drug development in cases where randomized, controlled trials pose a particular challenge.

Given Rachel Sherman Partners’ 30+ years of unparalleled expertise in medical product development, regulation, and policy, we make sure our clients can navigate the complex pathways for developing and marketing medical products. In addition to supporting client efforts to navigate ongoing changes at FDA, Rachel’s recent successes on behalf of clients include:

  • Analyzing the regulatory landscape of program areas to enhance client submissions

  • Smoothing interactions with FDA to achieve productive meetings

  • Managing the resubmission of compounds to treat rare diseases when other attempts have failed

  • Rapidly interpreting and implementing regulatory advice, including resolution of contentious complete response letters (CRLs)

  • Preparing clients for FDA advisory meetings preceded by negative agency comments

  • Resolving clinical holds by rapidly addressing Agency concerns

  • Carrying out due diligence for investments

  • Preparing organizations to leverage large government contracts

  • Helping clients successfully resubmit applications following CRLs indicating non-approval

  • Ensuring that a client achieved a very positive advisory committee meeting (and vote), despite a previous CRL (and Agency posting of very negative premeeting documents); specific successes involved helping the client reestablish communication with the Agency; rapidly resolving the clinical hold decision; and successfully refiling the application

  • Assisting multiple clients to resolve clinical hold decisions by revising and refining the development pathway for their products

Whether you’re seeking a long-term consulting relationship or just want to touch base with a single question, we are here to assist you.

 

 

Let’s talk

We can help you with your program or project. Contact us today to learn more about Rachel Sherman Partners, LLC, and how we can be partners for innovation.

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