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Certara is the largest and most comprehensive provider of biosimulation (modeling and simulation), strategic pharmacometrics, and regulatory writing consulting services. Our multidisciplinary team works alongside clients to inform key drug development decisions and expedite the processes around achieving regulatory milestones.
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Certara biosimulation (model based drug development and informatics) software portfolio is the most wide-ranging in the industry. Certara technology is relied upon by over 1,500 biopharm companies and academic institutions for drug research and development.
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Certara combines its industry renowned pharmacometric and regulatory consultants with our vast software portfolio to provide services that focus on specific outcomes, therapeutic areas, regulatory milestones, and specific populations.
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Certara Launches a Strategic Drug Development Consulting Company in China
January 12, 2016
PRINCETON, NJ – Jan. 12, 2016 – Certara®, the global biosimulation technology-enabled drug development company, today announced the launch of Certara Strategic Consulting China in Shanghai. This new company is being led by President and CEO Christine Yuying Gao, MD, PhD, former vice president of consulting services at Quantitative Solutions, a global pharmacometrics consulting company. Quantitative Solutions merged with Certara’s Pharsight Consulting Services in July 2015 to form Certara Strategic Consulting.
“The recent announcement that the China Food and Drug Administration has introduced new procedures for drug registration and approval demonstrates China’s commitment to increasing innovation in its healthcare system. Biosimulation is an innovation that will not only expedite bringing safer therapies to market, but also will support China’s expansion of its fast-track drug approval process. We are delighted to be able to provide biosimulation consulting support for our clients in China,” said Certara Chief Executive Officer Edmundo Muniz, MD, PhD.
Certara Strategic Consulting provides outsourced drug discovery and development modeling and simulation, and strategic pharmacometric services to more than 100 biopharm companies, non-profit foundations, and regulatory agencies worldwide. It also uses model-based meta-analysis to increase drug development productivity, quantitatively inform portfolio management, and improve clinical trial success. In addition, the organization’s unique clinical outcomes databases enable it to analyze the comparative effectiveness of a new drug within its competitive landscape.
“We are just starting to see the profound impact that biosimulation, model-based meta-analysis, and comparative effectiveness analysis can have on a drug candidate’s development, regulatory review, and clinical application. Certara can assist clients in maximizing their efforts at each of these stages,” said Dr. Yuying Gao.
Certara Strategic Consulting’s therapeutic areas of expertise include oncology, cardiovascular, orphan/rare diseases, central nervous system, pediatrics, immunology, infectious disease, metabolic and endocrine disease, women’s health, pain, respiratory and ophthalmology.
Dr. Yuying Gao has more than 20 years’ experience in clinical pharmacology research and drug development. She has partnered with more than 50 pharmaceutical companies and modeled more than 100 compounds in clinical development.
Dr. Yuying Gao conducted her postdoctoral fellowship in clinical pharmacology at the Department of Anesthesia, Stanford University School of Medicine. She received her PhD in clinical pharmacology from the Jiaotong University School of Medicine and her MD in medical science from the Shanxi Medical University in China.
About Certara
Certara is a global biosimulation and regulatory writing company, committed to optimizing drug development decisions. Its clients include hundreds of international biopharmaceutical companies, leading academic institutions, and key regulatory agencies. Certara’s solutions, which span drug discovery through patient care, increase the probability of regulatory and commercial success by using the most scientifically-advanced modeling and simulation technologies and regulatory strategies. For more information, visit www.certara.com.
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