Regulatory Rules


Managing the significant requirements needed for medical device and pharmaceutical global regulatory approval takes knowledge, best practices and the right solution...

Your responsibility as an organization to meet compliance requirements such as FDA and EU regulations, is a complex and daunting task. Life sciences companies must accept that in the current regulatory environment, with agencies around the globe demanding complete lifecycle traceability of every product - accurate labeling is essential.

Built specifically for the life sciences industry, PRISYM 360 has sophisticated features, integral in its design, to provide the operational visibility and control that are critical in complying with global regulations. Integrated is an engine that allows rules to be defined specifying the content required to be on labels, dependent upon conditions such as label type, destination country, or product type.

  • Ability to stipulate defined requirements.
  • Rules conformance.
  • Reduce product recalls.


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