Medical Device Qualified Supplier Directory
Pacific BioLabs Company Profile
Qualifications: ISO 9001, ISO 13485, FDA Registered, CGMP Certified, Supplier to Medical Manufacturers
Markets Supplied: North America, Europe, Worldwide
Pacific BioLabs offers GLP/cGMP testing services to the biopharmaceutical, medical device, and combination product industries. PBL services include general toxicology, PK, radiolabeled ADME, potency bioassays, biocompatibility testing, cleaning and disinfection validations and sterility assurance, and pharmaceutical microbiology. The company specializes in preclinical studies in support of FDA and international regulatory submissions. PBL is AAALAC accredited and ISO 9001 and 13485 certified.