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Support for products used in regulated environments

With a regulatory support account, you get access to product documentation invaluable to process development and validation. The documentation is free of charge and is also critical for preparation of standard operating procedures (SOPs), quality control as well as clinical and marketing applications to regulatory agencies.

The subscription service helps you stay aware of when the regulatory support documents are updated. You can also subscribe to Change Control Notifications (CCN) to get notified of important changes to products used in regulated environments.

A few things to keep in mind:

  • Register with a company email address. A personal company email address is required for regulatory support documents. For the CCN service we recommend using a generic company address.
  • Once logged in, select the subscriptions you want.

Regulatory support service – available for Cytiva customers

With a registered account, you can subscribe to these documentation types:

  • Regulatory Support Files (RSF) for BioProcess chromatography resins, cell culture products, and more. Learn more
  • Validation Guides for single-use products, such as Xcellerex systems, Cellbag bioreactors, as well as ReadyToProcess products, process-scale filters, and more. Learn more
  • Validation Support Files (VSF) for software. Learn more
  • Extractables information for bioprocess single-use disposable products and certain hardware. Learn more
  • Change control notifications. Learn more
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