FDA Navigation
FDA regulation can be a complicated process for many companies looking to get FDA approval. Between 510(k), PMA's, EUA's, GMP practices, and Registrations/Regulations, STSC FDA consultants can guide you through the challenges to clear the regulatory process set by the FDA. Our FDA consultants have years of experience planning, preparing, testing, and helping companies maintain all regulatory and compliance matters regarding the development of medical devices within every device classification.
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As Celltrion brings their new over-the-counter Covid-19 test to the market, we have partnered with them to help distribute this test through private and public channels across the United States as the need for at-home testing is needed more than ever now. This product is for use under FDA Emergency Use Authorization (EUA) only.
In 2020 STSC and Nephron Pharmaceuticals broke ground on a new nitrile glove factory located in South Carolina. This was in response to the Covid-19 pandemic and the long-term need for PPE equipment made in the United States. This state of the art facility will supply private and public sectors with gloves for years to come.
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