About Us

About Us

At Sanger Health, we are a drug development regulatory consulting firm passionate about helping innovators cut through the regulatory landscape.
Founded by Matthew Lundberg, a lawyer with a scientific background and a deep empathy for both small and large biotech and pharmaceutical companies, Sanger Health is grounded in the belief that efficient and strategic drug development saves lives.
We specialize in pre-IND strategy, regulatory planning, IND submission support, and FDA communications. From early-stage development to IND preparation, we ensure your product has a clear and efficient path from discovery to first-in-human trials. Whether you're designing your initial clinical study or mapping out a long-term regulatory roadmap, we provide expert guidance tailored to your technology, team, and goals.
With deep expertise in early-stage drug development and a science-driven approach, we partner with emerging biotech teams to craft regulatory strategies that accelerate progress while reducing risk. We believe regulatory strategy should be a catalyst, not a barrier, to scientific innovation. That’s why our support is deeply personalized and fully aligned with your development vision.
What sets us apart is our efficiency, outcome-driven mindset, and genuine empathy for the challenges drug developers face. We work with biotechnology and pharmaceutical companies of all sizes to help them advance life-saving therapies with confidence.
Our mission is simple: make the regulatory process not just navigable, but strategic, so transformative treatments can reach the patients who need them.

Why Choose Us

With a background in law and a sharp focus on pre-IND regulations, we bridge the gap between innovation and compliance. We speak the language of both science and statute. Unlike general compliance consultants, we specialize in the drug-development industry—whether you're navigating FDA approvals, CMC requirements, or eCTD regulations, we know the terrain. We don’t just help you meet the minimum, we help you anticipate regulatory challenges and implement forward-looking solutions that avoid costly pitfalls. From preclinical pharmaceutical startups to mature biotech firms, we offer solutions that scale with your business and adapt to your product lifecycle—from R&D to post-market compliance.

Science-Based Background

We are consult on regulatory matters, but have the scientific background to properly understand our clients' needs.

Unmatched Expertise

We believe there is not a consulting firm as dedicated, educated and focused as we are on the regulatory matters that developers deal with on a daily basis.

Precise Results

We are an outcome-focused firm, with the end-in-mind at all times. Our fundamental goal is to help our clients realize their organizational goals.

Qualified Staff

We are highly educated in the law and regulations surrounding product development.