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Capability
From exploratory non-GLP pilot work through GLP-aligned documentation for IND-enabling studies, we support every regulatory stage, at the depth North American and international programs expect.
What we support
Pilot, proof-of-concept, and screening studies to guide program decisions.
Regulatory-track studies with GLP-aligned conduct and documentation.
Study designs and records matched to your regulatory strategy.
SOP-driven operations across in-life, sample, and data phases.
Sponsor audit access and structured records built for review.
Data packages suitable for FDA, EMA, MHRA, and PMDA where appropriate.
Move from exploratory to regulatory-track work without changing CROs or losing context.
Quality systems consistent with 21 CFR Part 58 and global GLP standards.
Named study directors and independent QA across GLP and non-GLP work.
Documentation maintained as part of study conduct, not reconstructed after the fact.
Quality & welfare
Exceptional care is the foundation of reliable data.
Yes. GLP and non-GLP study support is available for research clients. GLP applicability depends on protocol design, objectives, timeline, and facility fit, confirmed during protocol review.