The demand for sophisticated drug-delivery devices and combination products continues to drive novel product development and innovation within the medical device industry. At Pace Analytical, we understand that the convergence of drugs/biologics and devices bring exciting new opportunities, business, and a host of new challenges and regulations. Pace Analytical Life Sciences has the experience and expertise to embrace these opportunities and manage the challenges associated with drug device combination products.
We are uniquely positioned with extensive expertise to support the analytical testing needs of clients developing combination products. With our in-depth technical knowledge, state-of-the-art lab facilities and wide array of analytical services, Pace Analytical Life Sciences can provide our combination product clients with the analytical testing support and reliable scientific data that will withstand the scrutiny of regulatory approval. You can be assured that, when you work with Pace Analytical Life Sciences, you are working with a highly experienced, knowledgeable staff that will be there with you every step of the way.
Pace Analytical Life Sciences offers the following services to support the development of combination products:
- Analytical method development and 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 Solvents Testing
- Microbiology Support
- Physical/Mechanical Testing of Devices
- Stability Testing and Storage per ICH Conditions
- Protocol Writing Services
Contact me to learn more!