Meet your regulatory environmental obligations with pharmaceutical environmental risk assessments (ERAs) that predict substance risk of adverse effects of human medicines in the environment. ERAs are part of the requirements for market approval in many geographic regions around the world.  

• Extensive experience for a wide range of pharmaceutical products
• In-depth guidance of global regulatory guidelines—including EMA and FMA approaches
  
• Support for study design through to post-submission

We support your study with pre-study preparatory services such as dose formulation or surgical support—as well as post-life pathology and SEND data management for reporting outcomes. You’ll find a complete study experience, from planning to final report, enabling you to get the insights you need from your research.

• Dose formulation for dose selection and range finding analysis for single- and repeat-dose studies
• Advanced surgical capabilities for special intervention-related routes and study types 
  
• Pathology management for your study or as a stand-alone service, including digital pathology
  
• SEND data format ensures data is compliant/submission-ready, enabling new visualization

Save time and gain efficiency with a programmatic approach to drug development. Let us guide you through the long and complex scientific and regulatory process to maximize the value of your asset.

• Dedicated team of scientific, regulatory and program management advisors 
• Prospective plan to manage and communicate milestones, risk and budgets to stakeholders 
  
• Integrated insights across your program for smarter decision-making