Pace Life Sciences
★★★★★
3.8
/ 5
•
18 reviews
Pace Life Sciences offers expert chemical characterization services for medical devices and pharmaceutical products, ensuring patient safety and regulatory compliance. They support R&D through commercialization.
Pace Life Sciences provides comprehensive chemical characterization services crucial for ensuring patient safety and meeting regulatory requirements in the medical device and pharmaceutical industries. Their expert team utilizes advanced techniques to identify extractable and leachable compounds, providing essential data for toxicological risk assessments and product compatibility. As a FDA-registered and DEA-compliant facility adhering to cGMP standards, Pace Life Sciences supports clients from early-stage research and development through clinical trials and commercialization. Their secure client data portal, PacePort®, offers easy access to methods, specifications, and reports, facilitating efficient review and remote audits. They are committed to advancing science through sustainable practices and continuous innovation.
About
Pace Life Sciences provides expert chemical characterization services for medical devices and pharmaceutical products. They focus on ensuring patient safety and regulatory compliance throughout the R&D and commercialization phases. Their services support clients in navigating complex testing requirements.
Additional information
Pace Life Sciences assists clients with chemical characterization, a critical step in the medical device and pharmaceutical development lifecycle. This process is essential for demonstrating product safety and meeting stringent regulatory demands. Their support extends from initial research and development through to market launch, helping to streamline the path to commercialization.
Key Highlights
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Offers chemical characterization services for medical devices and pharmaceutical products.
Source
“Pace Life Sciences offers expert chemical characterization services for medical devices and pharmaceutical products, ensuring patient safety and regulatory compliance.”
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Provides data necessary for toxicological risk assessments.
Source
“Analytical characterization is required from a regulatory perspective and provides a foundation for toxicological risk assessments using the test article in its intended application.”
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Utilizes PacePort® for secure client data access and delivery.
Source
“PacePort® is our secure client data access portal and web-based data delivery system where you have access to methods, specifications, stability protocols, pull schedules, stability reports, final reports, sample receipt data, instrument raw data, and additional information at any time, from any location.”
Certifications & Trust Signals
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Supports quality and regulatory (US FDA) audits with high-quality scanned images.
Source
“The copies are offered in high-resolution and in color, giving your team easy and clear viewing for review. Scanned images are of sufficient quality that they are often used during quality and regulatory (US FDA) audits.”
Buyer Snapshot
Best for
- Medical device manufacturers seeking chemical characterization
- Pharmaceutical companies requiring product safety testing
- Organizations needing support from R&D through commercialization
How engagement typically works
- Collaborative support for regulatory compliance
- Expert-led testing and analysis
Typical deliverables
- Chemical characterization reports
- Biocompatibility testing data
- Regulatory compliance documentation support
Good to know
- Best when requiring specialized chemical analysis for product safety and regulatory approval.
HQ:
US
Languages:
English
Claim status:
Listed
Services & Capabilities
Biocompatibility Testing (ISO 10993 Program)
Countries:
United States, Europe
Industries:
Medical Devices
Pricing model:
Custom pricing
Iso10993 Standards Supported:
ISO 10993-18, USP <87>, USP <88>
Test Types Offered:
Cytotoxicity, Systemic toxicity, Genotoxicity, Other
Glp Compliant:
Yes
Contact Types Supported:
External communicating, Implant
Duration Types Supported:
Limited (< 24h), Prolonged (24h - 30d), Permanent (> 30d)
Rush Available:
No
Nda Support:
No
Has In House Toxicology:
Yes
Toxicology Capabilities:
Analytical characterization is required from a regulatory perspective and provides a foundation for toxicological risk assessments using the test article in its intended application. Our expert team adapts and applies regulatory guidelines to your device or container closure to ensure the study design and execution suit your product(s) and requirements.
Sample Requirements:
Sample receipt data is available via PacePort®.
Regions Served:
USA
Additional biocompatibility_testing Details
Iso10993 Standards Supported
ISO 10993-18
Test Types Offered
Chemical characterization
Pricing Model
Per project, Custom
