i3’s customers will have on-the-ground presence in China and in-depth regulatory expertise to help them gain entry into growing market
BASKING RIDGE, N.J., & SHANGHAI--(BUSINESS WIRE)-- i3, a global life sciences services company and subsidiary of Ingenix, has acquired ChinaGate, a contract research organization (CRO) that provides product-development regulatory services for pharmaceutical, medical device and biotechnology companies looking to enter and access the Chinese market.
ChinaGate has successfully guided customers – based in China and abroad – through China’s regulatory system to bring more than 450 medical and consumer health care products to the Chinese market. In addition, ChinaGate has helped its customers bring products manufactured in China to global markets.
ChinaGate has extensive experience with the State Food and Drug Administration (SFDA), China’s regulatory authority charged with oversight and supervision of drugs and medical devices. Its leadership team, composed of former senior managers and executives of global pharmaceutical companies, has global regulatory expertise, including with U.S. Food and Drug Administration (FDA), Canadian and EMEA regulations.
i3’s customers will benefit from ChinaGate’s on-the-ground presence and expertise in overseeing clinical trials, submitting filings, obtaining licenses and navigating the regulatory process. ChinaGate’s customers will gain access to development, data and commercialization services through i3’s global reach and capabilities that will help facilitate greater access to global markets. As a subsidiary of Ingenix, i3 offers systems, information, training, learning and development, and enabling technologies.
“ChinaGate’s experience with the SFDA and understanding of the Chinese regulatory process will be invaluable to the services we deliver to our customers,” said Glenn Bilawsky, CEO of i3. “With its reputation for specialization and quality, ChinaGate will enhance i3’s ability to help our customers expand and sustain their business in the important Chinese market.”
“Combining i3’s and ChinaGate’s knowledge, experience and expertise will enable us to offer clients more comprehensive services and continued results in one of the world’s fastest-growing pharma and medical-device markets,” said Joyce Chiu, CEO of ChinaGate. “We look forward to becoming part of i3 – one of the most respected clinical research and regulatory consulting firms in the world.”
The ChinaGate executive team, led by Chiu and Managing Director Janice Ma, will continue in their roles as ChinaGate integrates with i3’s Clinical Development Services group.
Market Opportunities in China
Global life science companies are increasingly turning to China to establish major research and development (R&D) capabilities and product development services. By 2020, China is targeting an investment of 2.5 percent of GDP into pharmaceutical R&D, putting China into a range comparable with that of the United States.
As disease patterns and prevalence in the Chinese population have begun to resemble those of the West, 75 percent of China’s total drug development pipeline is now in i3’s areas of therapeutic specialization, including oncology, central nervous system diseases, infectious disease, cardiovascular disease and endocrine/metabolic conditions.
i3 and ChinaGate global customers will benefit from enhanced capabilities. Whether customers seek a functional outsourcing relationship or require full-scale CRO services, i3 will be able to meet their needs more effectively and efficiently. ChinaGate’s office in Shanghai is near the Shanghai R&D Park, where the substantial majority of i3’s customers with operations in China are located.
ChinaGate is a contract research organization based in Shanghai, China, focused on providing regulatory consulting services to customers in the pharmaceutical, medical device and biotechnology industries as they navigate new products from clinical trial development, to regulatory approval, to post commercialization. ChinaGate’s professionals have deep experience working with regulatory agencies both in China and abroad. Please visit www.chinagate-healthcare.com for more information.
i3, a global Ingenix company, takes a 360-degree view of health care to help its global pharmaceutical, biotechnology, and medical device customers bring safe and effective products to market quickly and help demonstrate their value, leading to increased ROI and better patient care. i3’s integrated businesses combine a deep understanding of data and methodologies; therapeutic, scientific, and functional proficiency; and the expertise to help design research that demonstrates a product’s value, and helps achieve market access and assure reimbursement. More information about i3 can be obtained at www.i3global.com.
Ingenix, a UnitedHealth Group (NYSE: UNH) company, is a leading provider of health information, technologies, consulting and services. Organizations, institutions, businesses and government agencies that comprise the health care system depend on Ingenix solutions and insights to improve their performance. Visit www.ingenix.com for more information.
Brian Bennett, 501-225-9733
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