Pacific BioLabs offers a complete range of antibody services, immunochemistry procedures, and preclinical studies to support drug development and IND, NDA, and PLA submissions. Pacific BioLabs has standard protocols for many studies, or we can help you develop a custom protocol. During the last two decades, we have gained a national reputation for excellence in science, diligence in regulatory compliance, quality in service and reliable turnaround time. 

Pharmaceutical and biopharmaceutical tech companies rely on preclinical toxicology and pharmacology studies to:

• evaluate the efficacy of new drug products quickly and accurately
• provide critical information for clinical trials
• help ensure patient safety
• meet FDA and international requirements for new drug submissions

Pacific BioLabs’ experienced staff can work with you to design and execute cost-effective protocols for preclinical studies of biotech-derived products and traditional pharmaceuticals. Our rigorous quality assurance program and outstanding regulatory track record help guarantee there will be no surprises with your product submissions. Upon request toxicology studies can be performed with applicable GLP regulations.

Pacific BioLabs’ scientists have experience with a wide range of infectious and other disease state models for evaluating candidate therapeutics or prophylactic treatments. Our staff will conduct literature searches, collaborate with you on protocol design, and handle all aspects of IACUC review promptly and responsively.

Studies are conducted by well-trained Study Directors and technicians in compliance with Pacific BioLabs’ rigorous quality systems.

ANIMAL MODELS

Available species include:

Treatments may be administered via the following routes of administration:

Investigational Areas:

All testing complies with applicable Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP) regulations. Our animal facility is AAALAC accredited and USDA and OLAW compliant. Pacific BioLabs has an outstanding track record of regulatory compliance. We are committed to excellent client service and appreciate the opportunity to discuss your testing requirements.

Download printable version of our booklet Preclinical Toxicology - Points to Consider in Program Design (PDF).