Biologics Consulting is a full-service regulatory and product development consulting firm for biologics, pharmaceuticals and medical devices. Founded in 1993 by Dr. James Kenimer, who previously served more than 15 years at the Food and Drug Administration (FDA), 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.
In the nearly three decades since its founding, Biologics Consulting has built an unprecedented record of achievement, assisting clients all over the globe to address nonclinical, clinical, product development, and regulatory compliance challenges. In the past four years, we have served more than 1,000 unique clients, a quarter of whom were international; we have contributed to more than 50 original INDs, 75 BLAs/NDAs (full and supported); and produced more than 80 510(k)s, 10 PMAs and 42 IDEs.
The cornerstone of this success is found in our team of consultants and professional services staff, comprising subject-matter experts with decades of industry and/or FDA experience. It is this experience that allows us to provide an unparalleled "insider" perspective on how best to navigate your new product from discovery through testing, nonclinical work, clinical trials, regulatory approvals, and ultimately arrive at market in the most efficient manner.
We believe open communication and transparency are the foundation of a successful outcome for your new product. We don't believe in cutting corners or cookie-cutter approaches; we believe we have an obligation to provide an honest assessment, realistic timelines, credible science, accurate submissions, and an effective regulatory strategy. We hold ourselves to the highest standards of professionalism, scientific practice and ethics. We take 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.
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. Regardless of the stage of your product's development, Biologics Consulting has the insight and experience necessary to help you overcome the next set of challenges and bring your product to market in the most responsible and efficient manner possible. With a team of experts and an unmatched track record of achievement in both regulatory approval and product development consulting, rest assured that with Biologics Consulting on your side, you are in the best possible position for a successful outcome.