Reliable Combination Product Development
The demand for sophisticated drug-delivery devices and combination products continues to drive novel product development and innovation within the medical device industry. We understand that the convergence of drugs and devices bring exciting new opportunities, business, and a host of new challenges and regulations. Our team offers the experience and expertise to embrace these opportunities and manage the challenges associated with combination product testing and development.
With our in-depth technical knowledge, state-of-the-art lab facilities and wide array of analytical services, our team provides the analytical testing support and reliable scientific data capable of withstanding the scrutiny of regulatory approval. Our highly experienced, knowledgeable staff are there with you every step of the way.
We offer the following services to support the development of combination products:
- Analytical Method Development & Validation
- Assays / Impurity Profiles
- Drug Release / Elution Studies
- Dose Uniformity Studies
- Drug-Coated Device Testing
- Drug Device Testing
- Inhalation Drug Delivery Testing
- Metered-Dose Inhalation Testing
- Anderson Cascade Impaction / Next-Generation Impaction (ACI / NGI)
- Residual Solvent Testing
- Microbiology Support
- Physical/Mechanical Testing of Devices
- Stability Testing & Storage per ICH Conditions
- Protocol Writing Services
Finished Product Services
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.