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 is a provider of chemical characterization services for medical devices and pharmaceutical products. They focus on ensuring patient safety and regulatory compliance throughout the product lifecycle, from research and development to commercialization.
**Expertise & scope**
* Expert chemical characterization services for medical devices and pharmaceutical products.
* Evaluation of medical devices or packaging for materials in potentially hazardous quantities.
* Identification of extractable and/or leachable compounds in medical devices or container closure systems.
* Support for assessing the compatibility of materials to preserve drug product integrity.
* Adaptation and application of regulatory guidelines to device or container closure requirements.
* Development of a representative chemical profile of products.
* Secure client data access portal (PacePort®) for methods, specifications, stability protocols, reports, and raw data.
**Reputation / proof points**
* Supports R&D through commercialization.
* Provides data necessary for toxicological risk assessments.
* Offers high-resolution, color copies of documentation for clear review.
* Scanned images are of sufficient quality for quality and regulatory audits (US FDA).
* Information available via PacePort® supports remote audits.
* State-of-the-art facilities and highly trained experts.
Pace Life Sciences is a provider of chemical characterization services for medical devices and pharmaceutical products. They focus on ensuring patient safety and regulatory compliance throughout the product lifecycle, from research and development to commercialization.
**Expertise & scope**
* Expert chemical characterization services for medical devices and pharmaceutical products.
* Evaluation of medical devices or packaging for materials in potentially hazardous quantities.
* Identification of extractable and/or leachable compounds in medical devices or container closure systems.
* Support for assessing the compatibility of materials to preserve drug product integrity.
* Adaptation and application of regulatory guidelines to device or container closure requirements.
* Development of a representative chemical profile of products.
* Secure client data access portal (PacePort®) for methods, specifications, stability protocols, reports, and raw data.
**Reputation / proof points**
* Supports R&D through commercialization.
* Provides data necessary for toxicological risk assessments.
* Offers high-resolution, color copies of documentation for clear review.
* Scanned images are of sufficient quality for quality and regulatory audits (US FDA).
* Information available via PacePort® supports remote audits.
* State-of-the-art facilities and highly trained experts.
Additional information
Pace Life Sciences offers a secure client data access portal, PacePort®, which provides comprehensive access to analytical methods, specifications, stability protocols, pull schedules, stability reports, final reports, sample receipt data, and instrument raw data. This system is designed for anytime, anywhere access, facilitating efficient review and audit processes. The documentation provided is in high-resolution color, ensuring clarity for your team. Scanned images are of a quality suitable for regulatory audits, and the thoroughness of the data available can support remote audits, guided by their Quality Assurance personnel. Their scientific and professional services teams are available to provide additional support when needed.
Key Highlights
-
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.”
-
Provides data for toxicological risk assessments and regulatory compliance.
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.”
-
Utilizes a secure client data access portal (PacePort®) for methods and reports.
Source
“Analytical methods, including both the Client Laboratory Methods (CLM) and Laboratory Methods (LM), are available for your access and review in PacePort®.”
-
Supports remote audits with comprehensive data access and quality assurance guidance.
Source
“The information available via PacePort® is thorough and complete, such that most, if not all, aspects of a data audit are available so your audit could be conducted remotely, guided by our Quality Assurance personnel.”
Certifications & Trust Signals
-
Supports R&D through commercialization.
Source
“They support R&D through commercialization.”
-
Expert team adapts and applies regulatory guidelines to specific product requirements.
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
- Pharmaceutical companies
- Companies requiring chemical characterization for regulatory compliance
How engagement typically works
- Project-based support
- Collaborative scientific partnership
Typical deliverables
- Chemical characterization reports
- Extractable and leachable study data
- Toxicological risk assessment support data
- Secure data access via PacePort®
Good to know
- Best when requiring detailed chemical profiling and regulatory support for medical devices and pharmaceuticals.
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, Extractables and Leachables Testing
Pricing Model
Per project, Custom
