Research animal retirement and lifetime care, now available through Alpha Genesis. Professionally managed lifetime care for retired research primates, with expert social reintroduction into stable outdoor groups led by veterinary staff deeply experienced in laboratory-animal medicine.
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From exploratory non-GLP pilot work through GLP-aligned documentation for IND-enabling studies, Alpha Genesis supports every regulatory stage, at the depth North American and international programs expect, with quality systems, data integrity, and audit readiness at the core.
Understanding when to invest in GLP-compliant infrastructure, and when a well-documented non-GLP study best fits your scientific and budget goals, is one of the most consequential decisions in early drug development. Alpha Genesis helps sponsors navigate this choice by offering both study frameworks under rigorous, welfare-centered operations.
Our GLP-aligned documentation practices follow 21 CFR Part 58 principles, and, where electronic records and signatures are used, 21 CFR Part 11, including protocol control, study director oversight, raw data traceability, deviation management, and archive-ready reporting. These quality systems are built to be consistent with internationally recognized GLP expectations, including the OECD Principles of Good Laboratory Practice, so that the records we generate are suitable for international development programs as readily as domestic ones. For IND-enabling and global development programs alike, we execute studies whose data support review by major health authorities, including the FDA, EMA, MHRA, and PMDA, where appropriate, and coordinate with sponsors and their regulatory advisors to confirm that documentation depth, timeline, and study design align with those expectations before a single animal is enrolled.
Non-GLP programs retain the same high standard of animal care, veterinary oversight, and SOP-driven procedures. They offer flexibility for target identification, model development, dose-ranging, and mechanistic studies where formal regulatory submission is not the immediate objective. In either framework, animal welfare is the foundation of reliable data, ethical study conduct, regulatory confidence, and long-term client trust.
GLP/IND-enabling and non-GLP study support covers both rodent and NHP models, and running both under one integrated platform is a particular advantage for multinational programs that must present a single, coherent data set to several health authorities. For sponsors advancing toward an IND, we design IND-enabling studies with GLP-aligned documentation suited to the submission package, whether the program is bound for a single market or a coordinated international filing. For rodents, Alpha Genesis supports GLP and non-GLP studies in both rats (Rattus norvegicus) and mice (Mus musculus), for qualified programs and protocols; GLP suitability and scope are confirmed per protocol.
GLP and non-GLP program support is available for research clients across a broad spectrum of development stages.
Early-stage companies building IND packages benefit from GLP-aligned documentation and study director oversight that mirrors the quality expectations of FDA and other major health authority reviewers.
Non-GLP programs support hypothesis-driven work, model refinement, and mechanistic studies while still meeting IACUC and institutional reporting standards.
Contract organizations coordinating multi-site programs rely on our audit-ready documentation, deviation tracking, and SOP library to maintain data integrity across study phases.
Sponsors preparing IND, BLA, or international marketing-authorization packages depend on clean, traceable data packages, properly archived study records, and responsive QA communication.
Capabilities are matched to your program and available for research clients, spanning GLP/IND-enabling and non-GLP study support.
Our operational infrastructure supports both regulatory tiers without compromising procedural rigor.
Dedicated study directors and scientific project management anchor every program, backed by board-certified laboratory-animal veterinarians, 24/7/365 clinical care, and preventive medicine. Animal welfare, environmental enrichment, behavioral management, and continuous health monitoring, is treated as the foundation of reliable data across both rodent and NHP work. GLP quality systems, SOP-driven operations, and electronic documentation deliver inspection-ready records for sponsors and regulators across U.S. and international jurisdictions. AAALAC International accreditation and USDA licensure, with OLAW assurance under the PHS Policy and IACUC oversight, back the full compliance stack. GLP programs are conducted consistent with 21 CFR Part 58; where electronic systems are used for records and signatures, practices are aligned with 21 CFR Part 11 where applicable.
Every study, regardless of regulatory tier, operates under the same welfare-first principles. Reliable data begins with animals that are healthy, appropriately housed, and ethically managed.
Decades of NHP husbandry, health monitoring, and in-life study conduct give sponsors confidence in species-specific expertise that is difficult to replicate.
Board-certified and experienced veterinary staff provide clinical oversight, preventive medicine, and endpoint guidance throughout every study.
Many programs begin in rodent models and transition to NHP for translational confirmation. Managing both internally minimizes handoff risk and preserves protocol consistency, an advantage for multinational programs that must present one coherent data story to several health authorities.
Dedicated study management, proactive communication, and flexible scheduling help sponsors meet their development timelines without compromising data quality.
Government and commercial program experience across a range of therapeutic areas means our teams are prepared for the complexity and audit exposure that serious drug development demands.
GLP-aligned studies follow 21 CFR Part 58 principles, with electronic records and signatures aligned with 21 CFR Part 11 where used, including formal protocol control, study director accountability, QA involvement, and archive-ready documentation. Non-GLP studies use the same SOP-driven procedures and veterinary oversight but without the full regulatory documentation layer, making them well-suited for exploratory work, model development, and early dose-ranging.
Whether your program calls for GLP-aligned documentation or a streamlined non-GLP approach, our team will help you match the right framework to your scientific and regulatory goals, whether you are filing in North America, Europe, or on a global timeline.
