Nonclinical Efficacy Testing » Non-Clinical CROs and Agencies » PharmaLegacy

PharmaLegacy

PharmaLegacy is a Shanghai-based contract research organization (CRO) specializing in nonclinical pharmacology. This article provides an overview of the company’s core strengths, its portfolio of disease models, and representative preclinical study examples.

Features of PharmaLegacy’s Contract Services for Non-Clinical Studies

Extensive experience supporting IND submissions to the FDA and CFDAP

PharmaLegacy has supported numerous clients in filingInvestigational New Drug (IND) applications with both the U.S. Food and Drug Administration (FDA) and the China Food and Drug Administration (CFDA).
The company’s animal facilities are fully accredited by AAALAC International and house a broad range of species, including rodents, rabbits, other small laboratory animals, and non-human primates (NHPs). All operations are conducted in accordance with GLP standards and quality assurance (QA) best practices.

Large-scale animal facilities with strong capabilities in NHP studies

With particular strengths in non-human primate studies, PharmaLegacy operatesa 380,000-square-foot facilitythat includes120,000 square feet of SPF and conventional animal housing space.The facility can accommodate up to 350 NHPs, as well as approximately 30,000 rodents and large laboratory animals.

Robust PK/PD study capabilities

PharmaLegacy’s PK/PD research is built on a set of core principles, including appropriate animal model selection and handling, ethical dosing and administration practices, and accurate efficacy assessment across multiple disease models.
The company’s diverse portfolio of validated models is designed around these principles, enabling clients to generatePK/PD data with strong scientific validity and translational relevance.

Examples of Disease Models Available at PharmaLegacy

PharmaLegacy maintains a portfolio of more than 1,500 validated animal modelscovering a wide range of therapeutic areas, including oncology, bone diseases, autoimmune disorders, and inflammatory conditions.
For example, the company offers multiple preclinical models of acute renal disease, allowing for detailed evaluation of treatment effects on disease pathophysiology. In addition, PharmaLegacy provides carefully engineered heart failure models—such as myocardial infarction, myocardial ischemia–reperfusion, and pressure overload–induced hypertrophy—designed to closely recapitulate human cardiac pathology.

PharmaLegacy Non-Clinical Case Study

MCD diet–induced NASH model

PharmaLegacy’s non-alcoholic steatohepatitis (NASH) models offer flexible options tailored to the specific disease characteristics under investigation. In one representative study,a NASH model was established in male Wistar rats by feeding a methionine- and choline-deficient (MCD) diet for eight weeks, resulting in the induction of NASH.Following disease establishment, animals were treated with either vehicle or a reference compound over an additional eight-week study period.

Reference: PharmaLegacy official website (https://www.pharmalegacy.com/indications/hepatic-renal-disease-models/nafld-nash/)

PharmaLegacy Company Information

PharmaLegacy is a China-based CRO with extensive experience, a broad range of validated disease models, and deep expertise in nonclinical pharmacology. The company’s scientific staff has an average of more than 15 years of experience in pharmacological research, enabling the generation of high-quality and reliable pharmacology data across multiple disease areas.

AddressEast T3-2, 121 Longgui Road, Jinqiao Free Trade Zone, Shanghai, China 201201
Tel+86-21-6176-5100*8051
Websitehttps://www.pharmalegacy.com/

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
SMC Laboratories, Inc.
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
Charles River Laboratories
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
Inotiv
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.

By Therapeutic Area
Disease Animal Models
and Reviews
Proven Capability, Expertise and Track Record
Top 3 Non-Clinical CRO Services