Pre-Clinical Phase Services and Solutions for BioPharma

Build confidence in your drug candidate

Discover a comprehensive range of services, including laboratory and study design support, regulatory consulting, and FDA guidance, designed to ensure the safety and success of your drug candidate. Explore our BioPharma capabilities and resources to gain confidence in the safety and efficacy of your drug candidate, building a strong foundation for successful clinical trials.

Seeking Ways To Ensure Participant Safety In First-in-Human Trials

Learn about regulatory guidelines for first-in-human trials.

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Key Strategies for Speeding Time to Clinic

Getting to First-in-Human Clinical Trials: A make-or-break milestone for small biopharmas.

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Writing Guide for First-in-Human Trials

Reference this checklist to help you draft phase-appropriate chemistry, manufacturing, and controls (CMC) modules for the common technical document (CTD).

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Pre-clinical BioPharma resources

Solution driven resources built to simplify and accelerate your work while allowing you to proceed with confidence as you test and optimize your lead candidate and prepare for the clinical trial phase.