Pacific Biolabs Inc

Pacific BioLabs is a contract research organization (CRO) providing life science testing services for the medical device, pharmaceutical, and biotechnology industries. Founded in 1982 and headquartered in Hercules, California, the company specializes in preclinical and regulatory studies, including toxicology, biocompatibility, pharmacology, analytical chemistry, sterility assurance, and microbiology. Its operations are built upon a quality system aligned with current Good Manufacturing Practices (cGMP) and Good Laboratory Practice (GLP) regulations, and the laboratory maintains ISO/IEC 17025:2017 accreditation to ensure technical competence and compliance with international standards.

These services support clients in navigating the complex regulatory requirements for product safety and development submissions. By providing specialized testing capabilities, Pacific BioLabs helps manufacturers meet FDA and EPA expectations for product validation and quality control. The company operates a purpose-built facility where it performs a wide range of analytical and biological tests, serving as an outsourced partner for organizations that require rigorous scientific assessment to advance their life science products from development through regulatory approval.