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Services

Medical Devices

Over the years, ENCO Pharmaceutical Development, Inc. has cultivated an expertise in the medical device field. Working closely with our customers we have been able to apply our expertise to a variety of medical devices for both performance and release testing.

It takes a different approach to be able to successfully work with a variety of devices due to the extra level of complexity these apparatus can bring to the analytical evaluation of a product. Medical devices cover a very broad range of technologies and intellectual properties. They can be as simple as a tongue depressor or as complicated as a drug delivery device used for delivery of medicaments to the lungs.

The FDA's definition of a medical device is addressed under Section 201(h) of the Federal Food Drug and Cosmetic (FFD&C) Act, and are regulated under the FDA's Center for Device and Radiological Health (CDRH). Drug delivery devices are also handled under FDA's CDER Branch.

ENCO Pharmaceutical Development, Inc. has experience in a broad range of customer- and device-specific analytical techniques. Ranging from the characterization of raw materials for acceptance to the evaluation of finished products to design specifications, ENCO Pharmaceutical Development's team of scientists and professionals can assist you in streamlining your device's manufacture, regulatory approval and production.




Formulation |  Analytical Methods |  Stability Studies |  Raw Materials |  Characterization |  Medical Devices |  Quality Assurance


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