Drug Safety Assessment

Pharmaron is an experienced drug safety assessment CRO that comprehensively evaluates the safety of new therapeutic candidates. With strategic locations in China, the US, and the UK, we provide an all-encompassing drug safety assessment service across all phases of development.

Connect with a Scientific Expert

End-to-End Testing Platform

Our global reach and expertise as CRO ensure seamless transitions at every stage of our partners’ drug development journey, from drug discovery to preclinical and clinical toxicology assessments supporting our partners’ IND, NDA, BLA, 510k, and PMA submissions.

Fully Compliant Toxicology CRO

Pharmaron’s GLP safety assessment accreditations and AAALAC-accredited facilities underscore our commitment to the highest quality standards. Regular inspections by global regulatory authorities—including the FDA, OECD, NMPA, and MHRA—ensure compliance with international standards, providing our clients with peace of mind and making Pharmaron a trusted choice.

All Modalities Supported

Alongside small molecules and biologics, our expertise in toxicology assessment extends to vaccines, cell and gene therapy (CGT) safety assessment, and medical devices.

Leveraging our Expertise for Your Success

Our dedicated team excels in collaboration and problem-solving, leveraging deep regulatory expertise and direct engagement with regulatory officers. By proactively anticipating challenges, our clients rely on us for successful regulatory applications.

Drug Safety Assessment Services	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.

Why choose Pharmaron as your Toxicology CRO?

Immediate study starts with rodents or large animals
Industry-leading timelines
State-of-the-art facilities, fully accredited and regularly inspected by all major regulatory authorities
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.