Alpha Genesis, Inc. is a preclinical research organization and animal resource supplier in Yemassee, South Carolina. Its own structured site description reads: "AAALAC-accredited, USDA-licensed preclinical research and animal-resource partner providing integrated CRO services, nonhuman primate supply, contract breeding, NHP imports, quarantine and global logistics, bioproducts, and rodent GLP and non-GLP study capabilities."[S3] The company states that it maintains its own non-human primate colony[S1] and that it added rodent study capability in July 2026.[S10] This profile summarizes the services, stated compliance information, and company facts most relevant to US sponsors.
Nonclinical services relevant to US drug developers
Pharmacology and PK/PD
The company describes "efficacy, mechanism-of-action, dose-response, PK sampling, and PD biomarker studies in rodent and NHP models, with GLP and non-GLP support for IND programs."[S4] It states that "serial PK sampling, bioanalysis coordination, and PD biomarker collection are integrated into study execution, not treated as add-ons,"[S4] and describes PK sampling as being done "within veterinary-reviewed blood-volume limits."[S4] Note the word coordination. The cited page does not state which laboratory performs the assays or who selects it, and sponsors should confirm both before contracting.[S4] An IND is not "approved" by FDA: under 21 CFR 312.40 it goes into effect 30 days after FDA receives it unless FDA imposes a clinical hold.[R1] A CRO may conduct and report nonclinical studies that a sponsor includes in an IND, but it cannot guarantee that FDA will allow the clinical investigation to proceed.
Toxicology and safety
The toxicology page lists "single- and repeat-dose toxicity, MTD, safety pharmacology, clinical pathology, and histopathology coordination in rodent and NHP models for global regulatory submissions."[S5] Safety pharmacology endpoints, including an Irwin-type neurobehavioral battery where applicable, are offered within the toxicology program rather than as a separate service.[S5] As with bioanalysis, histopathology is coordinated rather than performed in house: the company states that "histopathology coordination [is] performed through qualified pathology partners."[S5] A developmental and reproductive toxicology capability is listed separately.[S6] A sponsor planning an IND-enabling package should map out who holds the study, who reads the slides and who runs the assays, since three organizations may be involved.
Animal supply, breeding, and import services
Alongside study conduct the company supplies research animals and runs related services: non-human primate and rodent supply, contract breeding and colony management, imports, quarantine and global logistics, and biospecimens and bioproducts.[S3] It states that it holds "more than 13,000 NHPs across three facilities, and still growing."[S1] Sponsors should confirm current animal availability, which party is responsible for import and quarantine, and the expected timeline for the proposed study, none of which is stated on the cited pages.
Quality, compliance, and animal welfare (as stated by the company)
GLP and accreditation. The company's quality and compliance page addresses GLP with reference to the FDA regulations at 21 CFR Part 58 and to electronic records at 21 CFR Part 11, and its own site description states that it is "AAALAC-accredited, USDA-licensed."[S3][S8] The company names FDA 21 CFR Part 58 in its GLP statement.[S8] GLP compliance is determined study by study under the applicable regulation, so sponsors should confirm in the protocol which regulation their study will follow and that the final report will carry the study director's compliance statement and the quality assurance unit's statement.[R2] AAALAC International accreditation is a voluntary evaluation of an institution's animal care and use program, re-evaluated every three years,[R3] and USDA registration and an OLAW Animal Welfare Assurance relate to the Animal Welfare Act and the PHS Policy respectively;[R4][R5] none of these establishes GLP compliance, which applies to individual studies.[R2] FDA does not approve or certify laboratories; registration with FDA does not denote approval.[R6]
Animal welfare statements. Because the company breeds and holds non-human primates, its animal welfare statements deserve to be read carefully and are reproduced here as the company's own words rather than summarized approvingly. It describes "professionally managed lifetime care for retired research primates, with expert social reintroduction into stable outdoor groups led by veterinary staff,"[S7] and its about page states that its chief executive "has guided Alpha Genesis with the conviction that rigorous science and uncompromising animal welfare are inseparable."[S2] This site does not evaluate, endorse or rank any company's animal care program, and the presence of a retirement program or an accreditation does not by itself describe the conditions in which a particular study is run. Sponsors with animal welfare requirements should inspect the facility and review the relevant protocols themselves.
95 Castle Hall Road, Yemassee, SC 29945, United States. This address appears on the company newsroom rather than on the main website, which shows only a phone number and email address[S9]
Not stated; no stock listing, parent company or investor is named[S2]
Leadership
Dr. Greg Westergaard, Chief Executive Officer, a primatologist by training; Xavier Westergaard, PhD, President[S2][S9]
Employees
Not published; the team is described as including veterinarians, clinical and research scientists and study directors[S2]
Sites
Three facilities; only the Yemassee, South Carolina address is published[S1][S9]
Colony (company statement)
More than 13,000 non-human primates across three facilities[S1]
Species
Non-human primates and, since July 2026, rodents[S3][S10]
Study services
Pharmacology and PK/PD, toxicology and safety, reproductive toxicology, safety pharmacology elements. Bioanalysis and histopathology are coordinated through outside partners[S4][S5][S6]
Animal resource services
NHP and rodent supply, contract breeding and colony management, imports, quarantine and global logistics, biospecimens and bioproducts[S3]
Compliance statements
Describes itself as AAALAC accredited and "USDA-licensed"; GLP addressed with reference to 21 CFR Part 58 and Part 11[S3][S8]. US research facilities are ordinarily USDA-registered rather than licensed, so the applicable registration and facility identifier should be verified[R4]
FDA ? "Is It Really FDA Approved?" (FDA does not approve health care providers, including laboratories; registration does not denote approval); FDA Compliance Program 7348.808 (GLP inspections of nonclinical laboratories). https://www.fda.gov/consumers/consumer-updates/it-really-fda-approved (accessed 2026-09-03)
3 Recommended Contract Research Organizations
for Non-Clinical Studies
— by Target goal and Expertise
In non-clinical development, the choice of contract research organization shapes the quality of the data and the time it takes to reach the next decision. Below, three CROs are introduced by the type of study they support: pharmacology (efficacy) studies, safety studies, and pharmacokinetic (PK/PD) studies. Each summary describes the services the company offers so that you can match a provider to your target and development objective.
Pharmacology (Efficacy) StudiesDisease-Relevant Models for Translational Drug Evaluation
Reference: SMC Laboratories, Inc. official website (https://www.smccro-lab.com/)
SMC Laboratories, Inc.
SMC Laboratories is a specialized non-clinical CRO focused on in vivo pharmacology and efficacy studies using disease-relevant animal models, particularly in fibrosis, inflammation, metabolic diseases, and oncology.
Areas of Expertise
Disease-Relevant Model Portfolio
SMC Laboratories offers models covering the liver, lung, kidney, intestine, and oncology. Its portfolio includes the proprietary STAM™ model for MASH, fibrosis, and hepatocellular carcinoma.
Study Design Based on Target Biology
Study plans are developed around the target biology, mechanism of action, disease stage, and development objective. Pharmacological endpoints can be combined with histopathology, biomarkers, and disease-specific readouts.
Support from Target Validation to Proof of Concept
With experience from more than 1,000 studies for clients in 30 countries, SMC Laboratories supports programs from target validation and candidate selection through in vivo proof-of-concept studies.
Safety StudiesComprehensive Safety Assessment for Preclinical Development
Reference: Charles River Laboratories official website (https://www.criver.com/)
Charles River Laboratories
Charles River provides non-clinical toxicology and safety assessment services for programs ranging from exploratory safety studies to IND-enabling development.
Areas of Expertise
General Toxicology Across Study Designs
Services include single- and repeat-dose toxicology, dose-range finding, and general toxicology studies across multiple species and administration routes.
Non-GLP and GLP Study Support
Charles River supports both non-GLP and GLP studies, allowing sponsors to progress from early safety characterization to studies intended for regulatory submissions.
Integrated IND-Enabling Safety Assessment
Toxicology studies can be integrated with toxicokinetics, clinical pathology, histopathology, and safety pharmacology to support interpretation and IND-enabling safety packages.
Pharmacokinetic (PK/PD) StudiesConnecting Drug Exposure with Pharmacological Response
Reference: Inotiv official website (https://www.inotiv.com/)
Inotiv
Inotiv provides integrated PK/PD, DMPK, and bioanalytical services to characterize drug exposure and its relationship with pharmacological response.
Areas of Expertise
Pharmacokinetic Characterization
PK studies characterize exposure, half-life, clearance, and other pharmacokinetic parameters needed to understand how a candidate behaves in the selected model.
Exposure–Response Evaluation
Pharmacokinetic data can be combined with pharmacodynamic endpoints and bioanalysis to evaluate the relationship between drug exposure and pharmacological response.
Integrated DMPK and Development Support
Integrated DMPK, pharmacology, and safety information supports candidate comparison, dose selection, dosing-frequency optimization, and decisions about subsequent preclinical development.
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