Performing analytical characterization of medical and combination devices ensures product 质量 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 im体育APP advantage
im体育APP'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), im体育APP’s laboratories are committed to delivering pharmaceutical testing services with the highest level of 质量 and control. Additionally, we are inspected regularly by the 食物 and Drug Administration (FDA) and Health Canada. This ensures the highest 质量 and safety of your product.
For more information about our analytical characterization services or to request a quote, contact us 今天.
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