Nonclinical and pre-clinical development

ICON experts will help to expedite your drug or medical device development program, providing insights and guidance to design the non-clinical program from the start, as well as support and expertise to enhance existing programs. Our nonclinical development experts will work with you to design and implement a cost-effective non-clinical program with a focus on shortening development timelines and ultimately to accelerate your product to market.

Expertise to deliver a fully integrated non-clinical programme

Clients leverage our wealth of experience and knowledge to navigate the development process efficiently, for small molecules, large molecules, biologics and medical devices. Our nonclinical team works closely with our CMC, clinical and regulatory groups to ensure that your nonclinical programme is integrated fully and not developed in isolation.

Comprehensive non-clinical development services

• Lead optimisation
• Development plans and study design
• Gap analysis, due diligence, troubleshooting and data interpretation
• In silico analysis to predict mutagenic potential
• Supplier selection, study execution and study management for:
  • Efficacy and safety pharmacology
  • Toxicology
  • ADME/PK
• Regulatory support and consultation, including:
  • Development of nonclincial content for submissions, including IND, CTA, NDA, MAA, 510(k) and PMA
  • Review of related nonclinical regulatory issues
  • Representation at regulatory agency meetings