Certara’s Phoenix Software for Drug Regulatory Reviews Adopts by Anvisa

Certara, the global leader in model-informed drug development and regulatory science, declared that the Brazilian National Health Surveillance Agency – ANVISA (Agência Nacional de Vigilância Sanitária) – is currently also employing Certara’s Phoenix WinNonlin software for reviewing into drug regulatory submissions.

Ellen Leinfuss, Certara’s Chief Commercial Officer said, “Phoenix WinNonlin is used by many Brazilian organizations to determine bioequivalence. It is recognized for expanding productivity, enhancing workflows, and ensuring high accuracy for studies of drug action in the human body”.

“Additionally, ANVISA’s adoption of this Phoenix software will ensure that reviewed studies follow good bioequivalence practices. Moreover, analysis outcomes generated by the organizations conducting bioequivalence studies and ANVISA will be completely compatible.”

Phoenix WinNonlin is considered as 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 gives integrated information projects, 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 researchers at more than 1,500 institutions in 60 countries.

Those organizations include the best pharmaceutical companies, scores of smaller biopharmaceutical companies, contract research organizations, and around 200 academic institutions.

Phoenix is also employed by many global regulatory agencies to assess 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.

Certara is a leading decision support technology and consulting organization committed to optimizing drug development and improving health results.

Certara’s solutions, which span drug discovery through patient care, use the most scientifically-advanced modeling and simulation technologies and regulatory strategies to expand the probability of regulatory and commercial achievement.


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