Morrisville, NC — Clinipace Worldwide, a global digital clinical research organization, announced the acquisition of Regulus Pharmaceutical Consulting, Inc, a regulatory affairs and quality assurance consultancy based in Boulder, Colo. With this acquisition, Clinipace Worldwide says it will significantly expand its regulatory and strategic development expertise. The company has increased its staff by 20% with new team members adding an average of 18 years experience in the life science industry. The Regulus team will remain in Boulder with the same management structure and personnel; and will operate as the Regulatory Affairs, Strategic Development, and Quality Assurance consultancy division of Clinipace Worldwide. In addition, the company further expands its in-house regulatory publishing and medical writing groups through the Regulus acquisition.
“Regulus’ expertise is a strategic fit for Clinipace Worldwide as they provide a unique resource of experience and skills to meet the requirements of our biopharmaceutical and medical device clients,” said Jeff Williams, Clinipace Worldwide CEO.
Since 2003, Regulus has successfully completed hundreds of regulatory projects for its international and North American clients. These projects include pre-IND, IND, CTA, IMPD, NDA, BLA, MAA, ANDA, DMF, Orphan Drug, and Packaging/Labeling submissions; FDA meetings and critical negotiations, and GMP and GLP audits, inspections, and remediation plans. The company is also regularly contracted for due diligence work on licensing and acquisition transactions in the life sciences.
Brenda Fielding, President of Regulus, will transition to executive vice president of Regulatory Affairs for Clinipace Worldwide, reporting directly to Christopher K. Porter, COO. Fielding will be responsible for directing all Regulatory Affairs and Quality Assurance consulting services from the Boulder office. She brings more than 20 years of experience, primarily in the area of regulatory affairs and quality. Prior to Regulus, she held senior management positions in US pharmaceutical and biotechnology companies. She has been involved in the successful clinical development of novel drugs, biologics, and drug delivery systems, over a wide range of therapeutic areas including oncology, anti-infectives, immunotherapeutics, and ophthalmology.
“Our combined offerings are a perfect fit for a client in need of comprehensive product development solutions,” Fielding says. “Together, we can ensure all relevant disciplines are involved in a clinical development project, from initial concept to regulatory strategy and submissions, quality systems implementation, clinical operations, through to the final delivery of the completed project.”
SOURCE: Clinipace Worldwide
