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
* Packaging and shelf-life testing
* cGMP and GLP compliant testing
* Services for pharmaceuticals, biologics, medical devices, combination products, and more
* Specific testing includes: Medical Device Shelf Life Testing, Contact Lens Solution Testing, Bioburden Testing, Sterility Testing, ICH Stability Testing, Method Development & Validation, Ion Chromatography (IC) Services, ICP-MS Trace Elemental Analysis, Food and Nutritional Supplement Testing.

**Reputation / proof points**
* Established in 1972
* FDA registered
* ISO 17025 accredited
* AAALAC accredited animal science operations

Additional information

Pacific BioLabs supports various stages of product development, from early-stage research to manufacturing support and clinical trials. Their services cater to a range of industries including pharmaceuticals, biologics, medical devices, and nutritional supplements. They emphasize quality systems, cGMP/GLP compliance, and continuous improvement in their testing processes. Buyers can engage Pacific BioLabs for services such as medical device shelf-life testing, packaging integrity, and stability studies for pharmaceuticals and biologics.

Key Highlights

  • Pacific BioLabs offers medical device shelf life testing. Source
    “Medical Device Shelf Life Testing”
  • They provide ICH Stability Testing for Pharmaceuticals and Biologics. Source
    “ICH Stability Testing for Pharmaceuticals and Biologics”
  • The company is FDA registered and ISO 17025 accredited. Source
    “PBL is FDA registered and is ISO 17025 accredited.”
  • Pacific BioLabs specializes in cGMP and GLP compliant testing. Source
    “specializing in cGMP and GLP compliant testing”

Certifications & Trust Signals

  • Established in 1972, Pacific BioLabs has decades of experience. Source
    “Established in 1972”
  • FDA registered. Source
    “PBL is FDA registered”
  • ISO 17025 accredited. Source
    “and is ISO 17025 accredited.”
  • AAALAC accredited animal science operations. Source
    “Our animal science operations are accredited by AAALAC.”

Buyer Snapshot

Best for
  • Companies requiring cGMP and GLP compliant testing
  • Pharmaceutical and biologics development
  • Medical device manufacturers
  • Nutritional supplement testing
How engagement typically works
  • Quote-based engagement
  • Direct client support
Typical deliverables
  • Stability study reports
  • Shelf-life testing data
  • Method validation reports
  • Microbiological testing results
  • Analytical chemistry reports
Good to know
  • Best when requiring accredited and compliant testing services.

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
Package integrity, Seal strength, Medical Device Shelf Life Testing
Standards Supported
cGMP, GLP, ISO 17025
Shelf Life Methods Offered
Real-time aging, Accelerated aging
Distribution Tests Offered
ICH Stability Testing
Lead Time Band
Start in 4-8 weeks
Quote SLA
< 24 hours
Sample Return Policy
Dispose
Minimum Project Size
$25-50k
Pricing Model
Per project
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