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Early programs often stall when nonclinical study design, animal-model selection, CMC timing, and regulatory expectations aren't aligned soon enough. Alpha Genesis helps sponsors build practical rodent and NHP study plans and execute the in-life work that supports pre-IND meetings, first-in-human readiness, and IND-enabling packages.
Alpha Genesis works with biotechnology, pharmaceutical, academic, and government sponsors to plan and run the nonclinical rodent and NHP programs behind an IND. We help align study design, species and model selection, sample collection, and timelines with your development goals, so the data you generate is the data your regulatory team needs.
We support IND-enabling nonclinical programs and pre-IND planning, and generate study data and reports that can support regulatory submissions. We work alongside your regulatory team, outside consultants, CMC partners, and bioanalytical providers, so the nonclinical package fits into the broader program rather than sitting apart from it.
From early planning through final study reports.
These are the decisions that determine whether a plan holds up scientifically and can actually run on schedule:
Start wherever your program is, from an early feasibility check to full study execution.
For early-stage sponsors deciding what animal studies are needed.
Deliverables may include
For sponsors preparing FDA interactions.
Deliverables may include
For sponsors ready to run studies.
Deliverables may include
What makes a nonclinical plan executable is direct control over the colonies, facilities, and veterinary teams that run it.
Run early rodent work and IND-enabling NHP studies with one CRO, with no handoff between stages.
Direct access to established NHP colonies and health-screened animals, so availability shapes the plan from day one.
Hands-on command of the import, quarantine, and acclimation steps that routinely gate IND timelines.
Laboratory-animal veterinarians involved from protocol review through study conduct.
Flexible support, from non-GLP exploratory and dose-range work through GLP-aligned IND-enabling studies.
Designs built on actual animal availability and facility capacity, informed by decades of work for pharma, biotech, academic, and government sponsors.
How we fit in
Alpha Genesis handles the nonclinical strategy and study-execution side of a drug-development program. Sponsors keep ownership of their regulatory submissions, clinical plans, and CMC work, and we coordinate directly with their regulatory teams, outside consultants, CMC partners, and bioanalytical providers so the nonclinical package fits the wider effort.
Related capabilities & services
Tell us about your candidate, target indication, and timeline. Our scientific team will help you scope the rodent and NHP studies that fit your development goals.
