About Pacific BioLabs, Inc.
Pacific BioLabs, Inc. (PBL) is a leading contract research organization (CRO) that provides preclinical and regulatory studies in toxicology, pharmacology, biocompatibility, sterility assurance and microbiology. The company has been serving the pharmaceutical, medical device and biotech industries for over 35 years.
PBL's state-of-the-art facilities are located in Hercules, California. The company's team of experienced scientists and technicians work closely with clients to design customized study protocols that meet their specific needs. PBL's services include testing of drugs, medical devices and other products for safety and efficacy.
One of PBL's core competencies is toxicology testing. The company offers a wide range of in vitro and in vivo assays to evaluate the toxicity of drugs or chemicals. These tests can help identify potential adverse effects on humans or animals before clinical trials begin.
In addition to toxicology testing, PBL also provides pharmacological studies to evaluate the efficacy of drugs or compounds. These studies can help determine optimal dosing regimens for clinical trials.
Biocompatibility testing is another important service offered by PBL. This involves evaluating how well medical devices or materials interact with living tissue. Biocompatibility tests are required by regulatory agencies before new medical devices can be approved for use.
Sterility assurance is another critical aspect of product development that PBL specializes in. The company offers a variety of microbiological tests to ensure that products are free from harmful microorganisms such as bacteria or fungi.
PBL has an impressive track record when it comes to meeting regulatory requirements for product development. The company has extensive experience working with the US Food and Drug Administration (FDA), European Medicines Agency (EMA) and other regulatory agencies around the world.
In addition to its core services, PBL also offers consulting services related to product development and regulatory compliance. Its team includes experts in areas such as quality control/assurance, project management, statistical analysis and more.
Overall, Pacific BioLabs Inc.'s expertise makes it an ideal partner for companies looking to bring new products through preclinical development into clinical trials while ensuring compliance with all relevant regulations along the way."