Resources

Laboratory Service Requests

Ready to initiate testing? Fill out and send in a Laboratory Services Request (LSR)

Booklet Downloads

Want to read a primer on biocompatibility, learn about toxicology, or see how to make sure your device complies with sterility requirements? Download one of our booklets:

Assessing Biocompatibility – A Guide for Medical Device Manufacturers (PDF)

 Sterility Assurance Compliance – A Guide for Medical Device Manufacturers(PDF)

 Preclinical Toxicology – Points to Consider in Program Design (PDF)

 Preclinical Toxicology – Guidance For Industry – ICH Guidances (PDF)

Pacific BioLabs Certification Forms

 Certificate of Registration: ISO 13485:2003 (PDF)

 Certificate of Registration: ISO 9001:2008 (PDF)

 PMDA GMP Approval (in Japanese) (PDF)

FDA Registration (click the link, then search for “Pacific Biolabs”)

GDUFA Registration, FEI #2914117

 AAALAC Accreditation (PDF)

Analytical Instrumentation

For a list of PBL’s analytical instrumentation please visit this page.

Test Project Status

Want to check on the progress of your testing? Call us at 510-964-9000, email your Client Account Manager, or email your project’s study director.

You may also send in a general contact form, and someone will respond to it by the next business day.

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