Brazilian Health Surveillance Agency, ANVISA, Adopts Certara’s Phoenix Software for Drug Regulatory Reviews

PRINCETON, NJ-Jan. 17, 2018-Certara®, the global leader in model-informed drug development and regulatory science, today announced that the Brazilian National Health Surveillance Agency – ANVISA (Agência Nacional de Vigilância Sanitária) – is now also employing Certara’s Phoenix® WinNonlin® software for reviewing drug regulatory submissions.   “Phoenix WinNonlin is used by many Brazilian organizations to determine bioequivalence. It is recognized for increasing productivity, improving workflows, and ensuring high accuracy for studies of drug action in the human body,” said Ellen Leinfuss, Certara’s Chief Commercial Officer. “In addition, ANVISA’s adoption of this Phoenix software will help to ensure that reviewed studies follow good bioequivalence practices. Furthermore, analysis results generated by the organizations conducting bioequivalence studies and ANVISA will be completely compatible.”    Phoenix WinNonlin is considered the industry standard for non-compartmental analysis, and pharmacokinetic/pharmacodynamic, and toxicokinetic modeling. It was purpose-built to automate and expedite many of the analysis steps required during the drug regulatory review process. Phoenix WinNonlin provides integrated data processing, post-analysis processing, table creation, and graphics tools for use in drug development projects.    In fact, Phoenix WinNonlin is used by more than 6,000 scientists at more than 1,500 institutions in 60 countries. Those organizations include the top pharmaceutical companies, scores of smaller biopharmaceutical companies, contract research organizations, and about 200 academic institutions. Phoenix is also employed by many global regulatory agencies to evaluate drug submissions. They include the China Food and Drug Administration, European Medicines Agency, Japan Pharmaceuticals and Medical Devices Agency, UK Medicines and Healthcare Products Regulatory Agency, and 11 divisions of the US Food and Drug Administration.     About Certara Certara is a leading decision support technology and consulting organization committed to optimizing drug development and improving health outcomes. Certara’s solutions, which span drug discovery through patient care, use the most scientifically-advanced modeling and simulation technologies and regulatory strategies to increase the probability of regulatory and commercial success. Its clients include hundreds of global biopharmaceutical companies, leading academic institutions, and key regulatory agencies. For more information, visit www.certara.com.