Click “Show More” below to read the answers to our most frequently asked questions (FAQs) about regulatory support.
A Regulatory Support File is a document containing both proprietary and non-proprietary information concerning one or more related BioProcess chromatography resins products marketed by Cytiva. The file may include information on performance, stability, extractable compounds, and analytical methods. It is an invaluable starting point for process development and validation, for preparation of standard operating procedures (SOPs) and quality control, and as support for clinical and marketing applications to regulatory agencies.
RSFs are continuously updated with new information. When the RSF to which you subscribe is updated, you will receive an email that new information is available.
A validation guide contains information such as product characteristics, material and requirement specifications, manufacturing process, qualification tests, or extractable compounds. VGs are available for single-use products such as Xcellerex bioreactors, WAVE Cellbag bioreactors, ReadyToProcess products and process-scale filters. VGs are continuously updated with new information. When the VG to which you subscribe is updated, you will receive an email that new information is available.
Validation Support Files for our softwares contain regulatory support documents that are an invaluable starting point for validation, preparing standard operating procedures (SOPs), and for supporting regulatory applications regarding production processes that utilize our softwares. When the VSF to which you subscribe is updated, you will receive an email that new information is available.
CCN is a web-based notification system concerning designated Cytiva products, where you subscribe to CCN for products of interest. When a notification is published for one of your subscribed products you will receive an email. CCN contains information regarding changes associated with the manufacture of products, in accordance with our standards.
Read more about the products concerned and our standards here.
Subscribers to regulatory support documentation receive notifications pertaining to changes in the content of the regulatory support documentation. CCN subscribers receive notifications pertaining to changes associated with the manufacture of products in accordance with our standards.
Read more about our standards here.
To avoid email notifications being classified as spam (unsolicited email), the system is designed so that the recipient must actively select to receive email notifications.
Due to the nature of the content of regulatory support documentation, a confidentiality agreement is required.When you request your first subscription to regulatory support documentation, you will be prompted to accept our confidentiality agreement online.
Users who only subscribe to CCNs do not need to sign a confidentiality agreement. Please note that you may only subscribe to CCNs that apply to products that you have purchased and that your access to the site may be suspended if you misuse the site to gain access to information about other products than the ones you’ve purchased.
The confidentiality agreement is personal to each individual end-user. Each user, subscribing to regulatory support documentation, must sign the confidentiality agreement on behalf of their company of employment.
The agreement is valid for one year. After one year, you will receive an e-mail to renew your agreement. You will also be prompted to renew the agreement online upon logging in to Cytiva.
When your agreement expires, you will still receive notifications for your regulatory support documentation subscriptions. However, you will not be able to access the files until you renew your agreement online.
The confidentiality agreement defines the use of the confidential information. Please consult your legal adviser.
Send an email to [email protected] to tell us who will be replacing whom. The new contact person has to be registered online before the RSF/VSF/VG or CCN subscriptions can be transferred. Please note that it is possible to register a generic company email address.
Please create a new account. Then inform us of the change at [email protected] and we will transfer your subscriptions.
Please note that it is possible to register a generic company email address.
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The advantage of the RSF is that it gives first-hand information to the user. The DMF is used by vendors in order to protect trade secrets and its content is only revealed to FDA reviewers. The RSF can be used worldwide, while the DMF for products other than the active ingredient (e.g., chromatography resin) is only applicable in the U.S.
While the DMF contains manufacturing information, the RSF provides a list of raw materials but no description of the manufacturing process. Neither the DMF nor RSF is subject to any authority approval. The contents are only reviewed in connection with a specific product application.