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:
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.
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.