Quality

Quality

Regulatory compliance and support

At CSP, we meet the needs of our customers in the pharmaceutical, medical device and food products industries with strict adherence to regulatory guidelines.

CSP helps assure product quality and our customers' compliance through:

  • FDA compliance – CSP plants meet requirements set forth by the U.S. Food and Drug Administration (FDA) and are compliant with the FDA's Current Good Manufacturing Practice (cGMP) Regulations. We engage leading outside counsel for guidance on all regulatory matters.
  • ISO-9001 certification – All CSP plants are ISO-9001 certified.
  • Materials compliance – All materials used in CSP products comply with FDA regulations.
  • Drug Master File – Our proprietary three-phase Activ-Polymer® formulations have a Drug Master File (DMF #14789) with the FDA, filed on March 23, 2000.
  • Compliance support – We proactively provide CSP customers with all testing and documentation required for their products' regulatory approval as quickly as possible. We strive to deliver whatever our customers need for their application process—including customized analytical testing.

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