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Regulatory & Product Development Consulting

Biologics Consulting is a full-service regulatory and product development consulting firm for biologics, pharmaceuticals and medical devices. Founded in 1993, Biologics Consulting has become the go-to consulting partner for companies large and small seeking to bring innovative, safe and effective products to market within the U.S.

Biologics Consulting was founded on the premise that biotechnology, medical devices, and pharmaceuticals hold the promise of a better future for everyone. Making good on that promise requires innovative approaches, world-class science, regulatory know-how and a team dedicated to bringing all of it together.

In the nearly three decades since its founding, Biologics Consulting has assisted clients all over the globe to address nonclinical, clinical, product development, and regulatory compliance challenges. We are FDA Consultants.


How We Work

The cornerstone of our ongoing client’s success is found in our team of consultants and professional services staff, composed of subject-matter experts with decades of industry and/or FDA regulatory experience. It is this experience that allows us to provide an unparalleled “insider” perspective.

We take great pride in delivering innovative solutions and extraordinary results for clients across the globe – and we know those results are a direct result of the care and commitment we bring to each client engagement.

Essentials for Successful Execution

We view ourselves as an extension of your team – your success partner, not as an outside consultant.

External Collaboration

Whether you’re a small innovator working on your first product or a large, multi-national conglomerate working on your next blockbuster breakthrough therapy, you will have our dedicated team working to support your product. With Biologics Consulting we will operate as a true extension of your team and integrate ourselves seamlessly into your existing product development processes and team dynamics.

Internal Collaboration

Collaboration is a cornerstone of Biologics Consulting – whether we’re educating one another on the latest Agency thinking or discussing how to navigate a particularly challenging scientific situation, our team is constantly sharing insights and best practices in an effort to expand our knowledge base and provide the best guidance to our clients. Our collaborative environment is driven by both our intellectual curiosity and our shared goal of providing our clients with value-added solutions to their problems.

Client Engagement

We Are Your Partner to Success

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