Pacific BioLabs
Pacific BioLabs is a leading CRO offering comprehensive life science testing services, including packaging and shelf-life testing. Established in 1972, they specialize in cGMP and GLP compliant testing for pharmaceuticals, biologics, medical devices, and more.
Pacific BioLabs is a premier Contract Research Organization (CRO) with extensive experience in life science testing, serving industries such as packaging, shelf-life, pharmaceuticals, biologics, and medical devices. Established in 1972, the company is dedicated to providing high-quality, reliable testing services, emphasizing robust quality systems and regulatory compliance. Their services encompass a wide range, including small molecule and biologics manufacturing and development support, clinical trial bioanalysis, and medical device testing. Pacific BioLabs is committed to continuous improvement and operates with cGMP and GLP compliance in mind, ensuring adherence to stringent industry standards. They are FDA registered and ISO 17025 accredited, with animal science operations accredited by AAALAC. Located in the San Francisco Bay Area, Pacific BioLabs is equipped to handle diverse testing needs, from extractables and leachables to antimicrobial effectiveness and shelf-life studies. They aim to be a trusted partner for clients seeking expert scientific support and timely results, striving to become a paperless laboratory with optimal workflows.
About
**Who they are**
Pacific BioLabs is a Contract Research Organization (CRO) established in 1972, specializing in life science testing services. They are FDA registered and ISO 17025 accredited.
**Expertise & scope**
* Comprehensive life science testing including packaging and shelf-life testing.
* Services for pharmaceuticals, biologics, medical devices, and combination products.
* Specialized testing such as ICH stability testing, ICP-MS trace elemental analysis, and medical device cleaning validation.
* Expertise in cGMP and GLP compliant testing.
* Offers Imunogenicity and Bioanalysis for Clinical Trials.
* Provides Medical Device Shelf Life Testing and Contact Lens Solution Testing.
**Reputation / proof points**
* Established in 1972.
* FDA registered.
* ISO 17025 accredited.
* Animal science operations accredited by AAALAC.
Pacific BioLabs is a Contract Research Organization (CRO) established in 1972, specializing in life science testing services. They are FDA registered and ISO 17025 accredited.
**Expertise & scope**
* Comprehensive life science testing including packaging and shelf-life testing.
* Services for pharmaceuticals, biologics, medical devices, and combination products.
* Specialized testing such as ICH stability testing, ICP-MS trace elemental analysis, and medical device cleaning validation.
* Expertise in cGMP and GLP compliant testing.
* Offers Imunogenicity and Bioanalysis for Clinical Trials.
* Provides Medical Device Shelf Life Testing and Contact Lens Solution Testing.
**Reputation / proof points**
* Established in 1972.
* FDA registered.
* ISO 17025 accredited.
* Animal science operations accredited by AAALAC.
Additional information
Pacific BioLabs supports various stages of product development, from early-stage research to manufacturing. Their services cater to a broad range of industries including pharmaceuticals, biologics, medical devices, and food/nutritional supplements. They emphasize quality systems, continuous improvement, and adherence to regulations and standards, including cGMP/GLP compliance. Buyers can engage with PBL for specific testing needs or comprehensive development support.
Key Highlights
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Pacific BioLabs offers specialized testing for medical devices, including shelf-life and cleaning validation.
Source
“Medical Device Shelf Life Testing”
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They provide ICH stability testing for pharmaceuticals and biologics.
Source
“ICH Stability Testing for Pharmaceuticals and Biologics”
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The company is FDA registered and ISO 17025 accredited.
Source
“PBL is FDA registered and is ISO 17025 accredited.”
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Pacific BioLabs has been providing life science testing services since 1972.
Source
“Established in 1972, they specialize in cGMP and GLP compliant testing”
Certifications & Trust Signals
Buyer Snapshot
Best for
- Companies requiring cGMP and GLP compliant testing
- Medical device manufacturers needing shelf-life and validation testing
- Pharmaceutical and biologics developers
How engagement typically works
- Direct engagement for testing services
- Quote-based project initiation
Typical deliverables
- Stability testing reports
- Validation reports
- Analytical and bioanalytical data
- Microbiology testing results
Good to know
- Best when specific life science testing is required.
Pricing
Model:
Custom pricing
HQ:
Hercules, US
Languages:
English
Timezones:
America/Los_Angeles
Claim status:
Listed
Services & Capabilities
Packaging + Shelf-life + Distribution Testing
Countries:
United States
Industries:
Medical Devices
Pricing model:
Custom pricing
Packaging Tests Offered:
Other
Shelf Life Methods Offered:
Accelerated aging, Both
Distribution Tests Offered:
Climate, Other
Standards Supported:
ISO 13485, FDA Guidance, Other
Is Accredited:
Yes
Accreditation Body:
ISO 17025
Has Climate Chambers:
Yes
Has Distribution Simulation:
Yes
Rush Available:
No
Nda Support:
No
Lead Time Band:
Start in 0-2 weeks
Quote SLA:
< 24 hours
Minimum Project Size:
No minimum
Sample Return Policy:
Dispose
Additional packaging_shelf_life_testing Details
Packaging Tests Offered
Other
Standards Supported
ISO 13485, FDA Guidance, cGMP/GLP Compliance
Shelf Life Methods Offered
Real-time aging, Accelerated aging
Distribution Tests Offered
Other
Lead Time Band
Start in 0-2 weeks
Quote SLA
< 24 hours
Sample Return Policy
Dispose
Minimum Project Size
No minimum
Pricing Model
Per project
