Safety Assessment & Toxicology

A full spectrum of Safety & Toxicology services from IND enabling to NDA submission.

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Safety Assessment & Toxicology

Streamlining your development process

Operating at sites in the US, Canada and China, Frontage provides all the resources you need to support your nonclinical safety research and development plans.

Our team of highly-experienced Study Directors, technicians, and program managers will help guide you through the critical phases of toxicity testing, from pilot tolerability and dose range-finding studies to definitive GLP toxicology studies required for the support of human safety.  

Pilot / Non-GLP Studies

The early phase screening and pilot tolerability/PK studies conducted in both rodent and nonrodent models form the foundation for the subsequent definitive (GLP) toxicology studies and are important elements in a successful, nonclinical safety evaluation program. These studies include maximum tolerated dose (MTD), repeat-dose range-finding, exploratory PK, and feasibility studies needed to justify the design and dose-level considerations for the pivotal studies to follow. 

GLP Studies

Frontage GLP toxicology studies have supported hundreds of successful client regulatory submissions globally. All standard dosing regimens and species (including nonhuman primates) are supported and are conducted in compliance with international GLP and animal welfare regulations.

Preclinical Safety: IND-Enabling and Later-Phase Toxicology Studies

Our GLP studies are conducted in a wide range of animal models as appropriate for either small molecule therapeutics or biologics, across a wide variety of therapeutic indications. These studies are often part of IND-enabling programs as well as later-phase development chronic, reproductive/developmental, and carcinogenicity studies needed to support large-scale human trials and marketing permits. 

Our fully-integrated IND-enabling programs include general toxicology plus genetic toxicology and safety pharmacology as appropriate, plus all affiliated analytical / bioanalytical support elements, enabling the collection of robust and comprehensive data packages for IND submission and support. From pilot screening to IND-enabling, and ultimately to studies needed for the NDA, we offer comprehensive expertise to help design, execute, and report the studies required to satisfy your planning and regulatory safety obligations.

Check Out Our Publication in International Journal of Toxicology

Hepatitis A Virus Infection in Cynomolgus Monkeys Confounds the Safety Evaluation of a Drug Candidate

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