Drug Safety Assessment

Pharmaron provides integrated drug safety assessment services supporting programs from discovery through regulatory submission. Supported by 1,100 scientists across China, the US, and the UK, we deliver in vitro and in-life safety assessment for drug development programs

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Why Choose Pharmaron for Drug Safety Assessment?

Support for small molecules, biologics, vaccines, cell and gene therapies, and medical devices
Approximately 4,000 GLP and non-GLP studies conducted annually
Rodent and non-rodent safety assessment capabilities
Regulatory support for global development programs

End-to-End Testing Platform

Our integrated testing platform supports safety assessment from early discovery through preclinical and clinical toxicology, helping advance programs toward IND, NDA, BLA, 510(k), and PMA submissions.

GLP-compliant and AAALAC-accredited

Pharmaron operates GLP-compliant, AAALAC-accredited facilities that are regularly inspected by global regulatory authorities, including the FDA, OECD, NMPA, and MHRA, helping ensure studies meet international regulatory expectations.

Scientific and Regulatory Expertise

Pharmaron’s regulatory teams support drug development programs through agency interactions and providing of submission-ready documents. We draw on 20 years of experience with regulatory authorities, help anticipate review concerns, avoid potential pitfalls, and improve the likelihood of a successful submission.

Drug Safety Assessment Services	Discovery	Preclinical	Clinical	Commercial
in vitro Toxicity Testing	Discovery	Preclinical	Clinical	Commercial
Regulatory in vitro Toxicology	Discovery	Preclinical	Clinical	Commercial
General Toxicology	Discovery	Preclinical	Clinical	Commercial
Safety Pharmacology	Discovery	Preclinical	Clinical	Commercial
Genetic Toxicology	Discovery	Preclinical	Clinical	Commercial
Developmental and Reproductive Toxicology	Discovery	Preclinical	Clinical	Commercial
Ocular Safety Assessment	Discovery	Preclinical	Clinical	Commercial
Regulatory Affairs	Discovery	Preclinical	Clinical	Commercial

A CRO with Toxicology Assessment Experience our Clients Rely on

Pharmaron’s extensive expertise in toxicology assessment ensures rigorous analysis and reliable results, which are crucial for clients seeking regulatory compliance and successful drug development. Our extensive experience is a testament to our long-standing expertise and industry leadership.

Toxicology studies conducted since inception

GLP toxicology studies conducted since inception

IND, NDA, BLA & 510(k) applications supported

Scientist in PPE reviews imaging data on a computer screen as part of an in vivo toxicology assessment in a controlled laboratory environment.

How Pharmaron Keeps Safety Programs Moving

Immediate study starts with rodents or large animals
Industry-leading timelines
IND-enabling package solutions with expert guidance
Direct communication with regulatory officers for proactive problem-solving to maximize the success of applications

Scientists in surgical gowns prepare for a preclinical procedure using a microscope, supporting drug safety assessment in a sterile lab setting to support NHP GLP tox studies.

Services supporting GLP Toxicity Assessment

Pharmaron provides comprehensive in-house drug safety assessment services, ensuring industry-leading timelines and guaranteed quality by maintaining all internal processes internally.

Medical devices are being tested in NHP for safety assessment

Specialty Safety Assessment

Some products or therapeutic indications require unique GLP safety evaluation services, which differ in terms of animal models, bioanalytical approaches, and regulatory guidance compared to other test substances.