Performing analytical characterization of medical and combination devices ensures product quality and regulatory compliance.
As medical and combination product prototypes are developed, analytical methods are required to provide loading with the necessary amount of drug. The drug must have the desired stability and release kinetics to allow for appropriate delivery and clinical evaluation.
Analytical characterization may include drug assays, degradation product identification and identification/quantification of extractables and leachables for product approval. Additionally, optimizing drug elution rates from combination devices improves device efficacy and safety.
The Element advantage
Element's analytical characterization of medical and combination devices is extensive and enables us to assist you with method development, method validations, and lot release testing. Our analytical specialists have the expertise and experience to get your product through a comprehensive testing program, shortening the certification process and getting your product to market quicker.
Specifically, we test for:
- Drug assays
- Drug elution rates
- Degradation product identification
- Residual chemicals (e.g., solvents and catalysts)
- Extractables and leachables
- Trace heavy metal content
With a strong track record of Good Manufacturing Practice (GMP), Element’s laboratories are committed to delivering pharmaceutical testing services with the highest level of quality and control. Additionally, we are inspected regularly by the Food and Drug Administration (FDA) and Health Canada. This ensures the highest quality and safety of your product.
For more information about our analytical characterization services or to request a quote, contact us today.
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Successful FDA 510(k) submissions are critical to your market success. Incomplete or inaccurate submissions can lead to failure and may delay your product launch.