Certara is not a CRO. Certara is the world’s largest expert drug development consultancy with almost 1,000 global employees, over 350 Pharm.D, PhD and MD drug development scientists, +250 regulatory scientists and regulatory strategists, +100 Market access specialists and +150 technology and software developers, applying a strategic and programmatic approach to drug development that maximizes our clients’ probability of both Regulatory and Commercial success, while mitigating economic risk by enabling efficient, effective informed decisions.  

• Each year since 2014, Certara’s Consulting Services and Technologies supported > 90% of all FDA novel approvals and advised on hundreds of programs from early clinical development stages through proof of concept.   

• Since 2017, Certara Strategic Consulting has helped its biotech clients create up to $44 Billion in value for their organizations and investors, through IPO’s, Out-licensing of drug assets and the sale of client companies to big pharma. 

The drug discovery and development process is long and expensive with more failures than successes. At Certara, we anticipate and address your critical drug discovery and development risks and decisions using biosimulation and tech-enabled services. 

In 2020, more than 1,650 customers worldwide chose Certara as their trusted partner for our gold-standard biosimulation software and tech-enabled services. As your trusted partner, we support confident decision-making throughout the entire biopharma R&D process to reduce cycle times, lower costs by minimizing the number of patients and clinical studies run and improve outcomes for patients. 

Additionally, 17 global regulatory agencies have adopted our Phoenix™ PK/PD and/or Simcyp™ PBPK Simulator software platforms, including the US FDA and EMA.