Guide8 min read
The IND-Enabling Studies Checklist
A comprehensive checklist of the preclinical studies required to support a successful IND filing, including safety pharmacology, toxicology, and ADME requirements.
15 June 2026
Resources & Insights
Preclinical Knowledge to Accelerate Your Drug Development
Access curated educational content, practical guides, and expert insights to help you navigate the complexities of preclinical drug development.
Informed Decisions Start Here
The preclinical development landscape is complex and constantly evolving. Our resources are designed to help biotech founders, scientists, and development teams make informed decisions at every stage of their program.
Regulatory Update6 min read
ICH M3(R2) Guidance: What It Means for Your Preclinical Program
A practical summary of the ICH M3(R2) guideline on nonclinical safety studies for the conduct of human clinical trials, with implications for study timing and design.
20 May 2026
Guide10 min read
Choosing the Right Animal Model for Your Oncology Program
An overview of the key considerations when selecting in vivo oncology models, including xenograft, syngeneic, PDX, and genetically engineered mouse models.
10 April 2026
Case Study12 min read
From Compound Library to IND in 18 Months: A CNS Case Study
How strategic preclinical planning and expert CRO oversight enabled a small biotech to achieve IND filing for a CNS compound in an accelerated timeline.
5 March 2026
Regulatory Update7 min read
FDA's Evolving Approach to 3Rs in Preclinical Testing
An analysis of recent FDA guidance on the replacement, reduction, and refinement of animal use in preclinical testing, and what it means for your development strategy.
18 February 2026
Guide5 min read
Understanding GLP vs Non-GLP Studies: When Each Is Required
A clear explanation of when GLP studies are required for regulatory submission, and when non-GLP studies are appropriate for early-stage development decisions.
22 January 2026
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