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Biologics Consulting Continues to Expand with the Addition of Three New Team Members

August 16, 2016  •  News
Posted In Other News & Insights

Biologics Consulting, a full-service regulatory and product development consulting firm for biologics, pharmaceuticals and medical devices, announced today the addition of three new consultants, further increasing the company’s capacity to deliver comprehensive scientific, technical and strategic guidance to clients in any stage of the regulatory approval and product development processes.

Kathryn Moore and HeeSun Lee join Biologics Consulting as Regulatory Project Managers, responsible for providing regulatory guidance, project management and FDA submission support for the firm’s clients. McKenzie Ruecker joins the firm’s e-Publishing Team as an Electronic Publishing Specialist, assisting clients with the publication of electronic IND, Master File, BLA and NDA submissions. With nearly two decades of combined experience, these new consultants bolster the growing team at Biologics Consulting.

“We are excited to welcome three new, highly-skilled experts to our growing team,” commented Norman Baylor, PhD, President & CEO of Biologics Consulting. “Each of these new team members brings a unique perspective, as well as knowledge and abilities that complement our current consulting staff. The addition of Kathryn, HeeSun and McKenzie allows us to expand our capabilities and meet the growing demand for regulatory and product development support. With these new hires, we continue to position the company to more effectively and efficiently assist our clients in navigating their products from concept to marketing authorization.”

About Biologics Consulting (
Biologics Consulting Group, Inc. 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 built a record of achievement, assisting clients worldwide with nonclinical and clinical, product development and regulatory compliance challenges.

Biologics Consulting has served more than 3,500 companies in 53 countries, and in the past four years, it has contributed to more than 50 original INDs, 75 BLAs/NDAs (full and supported), 80 510Ks, and 42 IDEs.

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