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
**Who they are**
Pace Life Sciences provides expert chemical characterization services for medical devices and pharmaceutical products, supporting R&D through commercialization to ensure patient safety and regulatory compliance.
**Expertise & scope**
* Evaluates medical devices and pharmaceutical container closure systems for extractable and leachable compounds.
* Supports toxicological risk assessments by providing data for intended applications.
* Adapts and applies regulatory guidelines to device or container closure requirements.
* Offers a broad spectrum of analytical methods to establish a representative chemical profile.
**Reputation / proof points**
* Provides secure client data access via PacePort®, including methods, specifications, stability protocols, and reports.
* Scanned images are of sufficient quality for quality and regulatory audits (US FDA).
* Remote audits are possible, guided by Quality Assurance personnel.
* Offers support from scientists and professional services in state-of-the-art facilities.
Pace Life Sciences provides expert chemical characterization services for medical devices and pharmaceutical products, supporting R&D through commercialization to ensure patient safety and regulatory compliance.
**Expertise & scope**
* Evaluates medical devices and pharmaceutical container closure systems for extractable and leachable compounds.
* Supports toxicological risk assessments by providing data for intended applications.
* Adapts and applies regulatory guidelines to device or container closure requirements.
* Offers a broad spectrum of analytical methods to establish a representative chemical profile.
**Reputation / proof points**
* Provides secure client data access via PacePort®, including methods, specifications, stability protocols, and reports.
* Scanned images are of sufficient quality for quality and regulatory audits (US FDA).
* Remote audits are possible, guided by Quality Assurance personnel.
* Offers support from scientists and professional services in state-of-the-art facilities.
Additional information
Pace Life Sciences utilizes PacePort®, a secure client data access portal, for web-based data delivery. This system provides access to analytical methods (Client Laboratory Methods and Laboratory Methods), specifications, stability protocols, pull schedules, stability reports, final reports, sample receipt data, and instrument raw data. High-resolution, color copies are available, often sufficient for remote quality and regulatory audits. Their expert team can adapt and apply regulatory guidelines to specific device or container closure requirements, ensuring study designs meet product needs.
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 secure client data access via PacePort® for methods, reports, and raw data.
Source
“Analytical methods, including both the Client Laboratory Methods (CLM) and Laboratory Methods (LM), are available for your access and review in PacePort®.”
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Supports R&D through commercialization phases.
Source
“They support R&D through commercialization.”
Certifications & Trust Signals
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Supports regulatory compliance and patient safety evaluations.
Source
“Protect patient safety with our characterization techniques. Characterization testing supports patient safety by evaluating medical devices or packaging...”
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Expert team adapts and applies regulatory guidelines to specific product needs.
Source
“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.”
Buyer Snapshot
Best for
- Medical device manufacturers requiring chemical characterization.
- Pharmaceutical companies evaluating container closure systems.
- Companies needing support for R&D through commercialization.
How engagement typically works
- Collaborative approach with expert scientists and professional services.
- Data access and review through a secure online portal.
Typical deliverables
- Chemical characterization reports.
- Data for toxicological risk assessments.
- Analytical method documentation.
Good to know
- Best when specific regulatory guidelines need to be adapted to unique product requirements.
HQ:
US
Languages:
English
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, Other
Glp Compliant:
Yes
Contact Types Supported:
Surface contact, External communicating, Implant
Duration Types Supported:
Limited (< 24h), Prolonged (24h - 30d), Permanent (> 30d)
Rush Available:
No
Nda Support:
No
Additional biocompatibility_testing Details
Iso10993 Standards Supported
ISO 10993-18
Test Types Offered
Chemical characterization, Extractables and leachables testing
Pricing Model
Per project, Custom
