Establish Product Functionality & Safety
Partnering with our team to perform your medical device testing enables you to select better materials, evaluate the effect of material degradation, and maintain reliable vendor management and raw material quality control. We offer comprehensive analytical support to help your medical device manufacturing establish your product functionality and safety.
Take advantage of the unique attributes both drugs and devices by developing your combination product with our team. Our experience in both aspects of treatment, drug and device, paired with our state-of-the-art facilities enables us to apply a comprehensive approach to development.
Establish your medical device’s biocompatibility by partnering with our team to identify and quantify the chemical components present in the materials. We pair this material characterization data with your intended applications to drive forward toxicological understanding.
Demonstrate your medical device’s safety, efficacy, and quality control with our microbiological support. We are highly experienced in a wide range of devices, microorganisms, and custom testing procedures to provide the necessary services and comprehensive results.
If your medical device requires terminal sterilization, we help satisfy the stringent requirements to demonstrate the applied sterilant is removed from the product and packaging. We are highly trained in and quantifying ethylene oxide (EO), and its common degradants, such as ethylene chlorohydrin (ECH) and ethylene glycol (EG).
PACKAGING
Performance testing of your product packaging is essential for the delivery of a safe and effective product. Our team provides a wide range of services evaluating the strength, integrity, materials, and labels of your packaging to ensure it satisfies key requirements.
STABILITY & STORAGE
Stability studies and shelf-life testing safeguards your products’ performance and regulatory compliance. We support studies for both short-term (accelerated) and long-term stability programs as well as photostability programs for both research and development and commercial products.
DISTRIBUTION
Distribution simulation testing provides a uniform and repeatable way of evaluating packaged products and packaging designs by utilizing standardized equipment and procedures to subject the packaging to anticipated hazards that may occur with routine distribution of packaged products.
Integrated Laboratory Services
When your team needs additional CDMO support, our scientists are ready. Our state-of-the-art facilities and highly trained experts can add power to your project.
Additional Resources
Pace® is a registered facility with the U.S. Food and Drug Administration (FDA), demonstrating our commitment to meeting regulatory requirements for quality and safety in the industries we serve.
Pace® holds a registration with the Drug Enforcement Administration (DEA), allowing us to handle controlled substances and support the specific needs of our clients in regulated industries.
Pace® adheres to current Good Manufacturing Practices (cGMP), ensuring that our laboratory facilities and processes meet the highest quality standards set by regulatory authorities for the pharmaceutical, biopharmaceutical, and medical device industries.
Pace® is accredited to ISO/IEC 17025, the international standard for competence in testing and calibration laboratories, validating our technical competence and commitment to delivering accurate and reliable results.