Acquisition to Expand Full-Service Regulatory Affairs and Quality Assurance Services
MORRISVILLE, N.C. (Business Wire) March 1, 2011 — Clinipace Worldwide, a global digital clinical research organization (dCRO), announced today the acquisition of Regulus Pharmaceutical Consulting, Inc., a Regulatory Affairs and Quality Assurance consultancy based in Boulder, Colorado. With this acquisition, Clinipace Worldwide significantly expands its regulatory and strategic development expertise. The company has increased its staff by 20 percent with new team members adding an average of 18 years experience in the life science industry. The Regulus team will remain in Boulder, CO 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.
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, Chief Operating Officer. Ms. Fielding will be responsible for directing all Regulatory Affairs and Quality Assurance consulting services from the Boulder, CO office. She brings over 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.
“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.
“Industry leadership and expertise from Regulus fuels our mission of partnering with our clients in bringing innovative therapies to market through our technology-amplified services in clinical development, regulatory affairs, and strategic development,” said Chris Porter, Clinipace Worldwide COO.
“Our combined offerings are a perfect fit for a client in need of comprehensive product development solutions,” said Brenda Fielding, Executive Vice President of Regulatory Affairs, Clinipace Worldwide. “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.”
About Clinipace Worldwide
Clinipace Worldwide, a global digital clinical research organization (dCRO), specializes in fully-integrated clinical research services for biopharmaceutical and medical device firms. Optimized by TEMPO™, its proprietary eClinical platform, the Clinipace team of experts brings extensive knowledge and insight into site selection, patient recruitment, clinical operations, data management, medical monitoring, biostatistics, regulatory affairs, strategic development, and quality assurance to ensure a successful clinical development program through proactive clinical trial management. With specific expertise in oncology, among other therapeutic areas, Clinipace Worldwide has managed over 200 contract research and regulatory projects. Clinipace Worldwide is headquartered in Research Triangle Park, NC with additional domestic operations in Overland Park, KS, and Boulder, CO, and South American operations based in Brazil, Argentina, and Peru.