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, established in 1972, is a Contract Research Organization (CRO) specializing in comprehensive life science testing services. They are FDA registered and ISO 17025 accredited.

**Expertise & scope**
* cGMP and GLP compliant testing for pharmaceuticals, biologics, medical devices, and combination products.
* Services include packaging and shelf-life testing, medical device cleaning validation, disinfection validation, contact lens solution testing, bioburden testing, and sterility testing.
* Specialized testing for small molecule and biologics development and manufacturing support.
* Clinical trial support, including immunogenicity and bioanalysis.
* Analytical and bioanalytical chemistry services, such as Ion Chromatography (IC) and ICP-MS trace elemental analysis.
* In vitro and in vivo testing capabilities.

**Reputation / proof points**
* Founded in 1972.
* FDA registered.
* ISO 17025 accredited.
* Animal science operations accredited by AAALAC.

Additional information

Pacific BioLabs offers a wide range of testing services to support product development and manufacturing across various industries. Their expertise extends to pharmaceuticals, biologics, medical devices, and even food and nutritional supplements. For buyers considering their services, it's important to note their strong emphasis on regulatory compliance, including cGMP and GLP standards, as well as ISO 17025 accreditation. They are equipped to handle complex testing needs, from method development and validation to stability testing and specialized microbiological assays. Engaging with Pacific BioLabs typically involves obtaining a quote, with direct contact information available for inquiries.

Key Highlights

  • Founded in 1972, Pacific BioLabs has extensive experience in life science testing. Source
    “Established in 1972, they specialize in cGMP and GLP compliant testing for pharmaceuticals, biologics, medical devices, and more.”
  • FDA registered and ISO 17025 accredited. Source
    “PBL is FDA registered and is ISO 17025 accredited.”
  • Offers specialized testing for medical devices, including cleaning validation and shelf-life testing. Source
    “Medical Device Cleaning Validation and Disinfection Validation Medical Device Shelf Life Testing”
  • Provides ICH stability testing for pharmaceuticals and biologics. Source
    “ICH Stability Testing for Pharmaceuticals and Biologics”

Certifications & Trust Signals

  • ISO 17025 accredited. Source
    “PBL is FDA registered and is ISO 17025 accredited.”
  • cGMP/GLP compliant testing. Source
    “they specialize in cGMP and GLP compliant testing for pharmaceuticals, biologics, medical devices, and more.”
  • Animal science operations accredited by AAALAC. Source
    “Our animal science operations are accredited by AAALAC.”

Buyer Snapshot

Best for
  • Pharmaceutical and Biologics Development
  • Medical Device Manufacturers
  • Combination Product Testing
  • Food and Nutritional Supplement Testing
How engagement typically works
  • Quote-based engagement
  • Direct client contact for inquiries
Typical deliverables
  • Shelf-life studies
  • Packaging integrity testing
  • Cleaning validation reports
  • Bioanalytical data
  • Microbiological testing results
Good to know
  • Best when requiring cGMP/GLP and ISO 17025 compliant testing.

Pricing

Model: Custom pricing
HQ: Hercules, US
Languages: English
Timezones: America/Los_Angeles
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

Additional packaging_shelf_life_testing Details

Packaging Tests Offered
Package integrity, Seal strength, Burst strength, Compression, Vibration, Drop, Other
Standards Supported
ISO 11607, ASTM D4169, ISTA, ISO 16775, ISO 13485, FDA Guidance, Other
Shelf Life Methods Offered
Real-time aging, Accelerated aging, Both
Distribution Tests Offered
Vibration, Shock, Drop, Compression, Stacking, Climate, Other
Lead Time Band
Start in 0-2 weeks
Quote SLA
< 24 hours
Sample Return Policy
Return, Dispose, Both options
Minimum Project Size
No minimum
Pricing Model
Per project
Request quotes
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