ABOUT US
OUR STORY
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About Rubicon Consulting
Jill Herendeen founded Rubicon Consulting to bring expert regulatory consulting for life sciences to startups and biopharma companies navigating complex approval pathways. Our mission is to make high-impact therapies accessible by supporting companies with tailored, compliant, and scalable solutions.
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Rubicon specialize in development and execution of global regulatory strategy across multiple regions including the US (FDA), United Kingdom (MHRA), Switzerland (Swissmedic), Europe (EMA), Japan (PMDA), Canada (Health Canada), and Australia (TGA), regulatory assessment of IND enabling GLP nonclinical data packages, and clinical study designs. Jill has decades of experience in oncology, autoimmune disease, and rare disorders and is dedicated to the development of novel therapeutics that address diseases with unmet needs by accelerating the development of biotech product approvals through intelligent, thoughtful, and balanced strategic execution of regulatory strategy.
Our Founder: Jill Herendeen, PharmD
Dr. Jill Herendeen founded Rubicon Consulting to support small and mid-sized biopharma companies lacking in-house expertise. Her 20+ years of regulatory consulting for life sciences includes success at global leaders (Amgen, BMS, AbbVie) and emerging innovators (Silverback, Orca Bio) drug development experience with global regulators including FDA, EMA, PMDA, Health Canada, Swissmedic, MHRA, and TGA, and has supported global filings including Vectibix® and Imbruvica®. Her leadership continues to guide Rubicon's clients through every step of end-to-end regulatory services, helping them reduce risk, hit milestones, and accelerate biotech product approvals.
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Crossing the Rubicon
The term "Rubicon" represents a point of no return, symbolizing a decisive commitment to action. In drug development and commercialization, crossing the Rubicon marks the critical moment when a company must invest its capital and limited resources to navigate today’s complex regulatory landscape. Rubicon provides expert regulatory guidance throughout the product lifecycle, ensuring a focus on quality, safety, and efficacy at every stage of development. Rubicon's shared goal is to expedite the development timeline and achieve marketing authorization, empowering you to confidently cross the Rubicon and accelerate patient access to innovative therapies.