• Tax and Regulatory Advisor

Certara is a clinical services organisation that leverages technology-enabled solutions to inform and optimise crucial drug development decisions. The company has amassed the most scientifically advanced modelling and simulation approaches and regulatory communications capabilities, and aligned them with proven and innovative drug development strategies to increase R&D productivity and the probability of commercial success for our clients. Certara provides outsourced capabilities from early R&D through to lifecycle management, with deep expertise in developing global drug development and regulatory strategies, representing clients at meetings with global health regulatory authorities, and assisting clients in preparing briefing books. Today, Certara is the largest and most comprehensive company of its kind. Certara has helped sponsors bring more than 80 drugs to market over the past several years, including 18 FDA-approved novel drugs in 2015. The company has a global footprint, with clients located in 60 countries, and staff located on four continents.

Certara’s expertise includes:

• Developing safer, targeted, more efficient trial designs
• Selecting first-in human, final dose, and dosing regimen
• Pressure testing and optimising drug development and regulatory strategies
• Representing clients at meetings with global health regulatory authorities and preparing briefing books
• Identifying drug-drug interactions and other safety concerns

Comparing drug candidates for safety and efficacy