Global Regulatory Partners

Guiding biotech and pharma through the regulatory grey space - where innovation meets approval.

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Experts in the Grey Space

At 5010 Consulting, we believe regulatory strategy should be both bold and pragmatic.

Innovation in biotech demands that regulatory leaders push boundaries while keeping compliance, patient safety, and integrity at the forefront. Our philosophy is to guide companies through the grey space - where progress happens, approvals are won, and the real difference is made.

Led by Mark Rutter, a regulatory executive with more than two decades of global experience, 5010 Consulting brings deep expertise across FDA, EMA, and international health authorities. Mark has:

  • Directed FDA Advisory Committee preparations, guiding high-stakes discussions with regulators and external experts.

  • Led the accelerated approval of a novel agent in SOD-1 ALS, shaping one of the most important neuroscience decisions in recent years.

  • Advanced pediatric expansion strategies in rare and non-rare conditions, demonstrating how innovative therapies can reach broader patient populations.

  • Supported global approvals in oncology, rare disease, and neuroscience, navigating complex regulatory pathways in multiple regions.

  • Authored countless position papers and advocated on behalf of industry and the rare disease community around the world.

This blend of hands-on corporate leadership and independent advisory perspective positions 5010 Consulting as the trusted partner for biotech and pharmaceutical teams seeking to accelerate development while managing risk.

Our commitment is simple: to deliver regulatory strategies that move the needle - and to help you achieve successful outcomes with clarity and confidence.

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Your Questions, Answered

Do you work with small and emerging biotech companies?

Yes. 5010 Consulting specializes in supporting early-stage and mid-sized biotechs, as well as established pharma.

How do consulting engagements typically work?

Flexible models: project-based, hourly, or ongoing retainer support depending on your needs.

Have you prepared for FDA Advisory Committees?

Yes - we have led high-stakes AdCom preparations, including successful accelerated approvals.

Do you work globally or only in the U.S.?

Extensive experience with FDA, EMA, and international regulatory authorities.

Let's Connect

Let’s connect to discuss your regulatory goals and challenges. Fill out the form and we’ll be in touch to schedule a time that works for you.