Click “Show More” below to read the answers to our most frequently asked questions (FAQs) about regulatory support.
In January 2023, the life sciences business of Pall separated from Pall Corporation. Pall’s biotech portfolio is now a product family in Cytiva’s bioprocess business. The Pall medical portfolio will remain a market brand and part of Cytiva. Pall Corporation continues to operate as a Danaher operating company serving customers across a wide range of industrial applications.
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.
Looking for information on agreements for Accelerator Regulatory Dossier for Allegro™ products? Scroll down, please.
For all products except Allegro™ products:
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 (Change Control Notifications) 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 have 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.
For Accelerator Regulatory Dossier for Allegro™ products:
Due to the nature of the content of regulatory support documentation, a confidentiality agreement is required. When you request access to the confidential document in the regulatory dossier, you will be prompted to accept the confidentiality agreement (NDA) via DocuSign. Please refer to the guidance document on How to submit an NDA request in the regulatory dossier.
Users who only subscribe to gated information do not need to sign a confidentiality agreement. Please refer to the guidance document on How to register an account and How to locate the document with regulatory dossier.
The confidentiality agreement is personal to each individual end-user. Each user who would like to review/download confidential regulatory documentation in the regulatory dossier must sign the confidentiality agreement on behalf of their company of employment. Please contact your sales representative/account manager if you have any enquiries regarding the NDA.
The agreement is valid for five years. After five years, if you wish to renew your agreement, please contact your sales representative/account manager.
For third-party documentation, you will need to submit a quotation request to the Global Sales Service Team. Please refer to the guidance document on How to submit a subscription in the regulatory dossier. Once you have subscribed to the dossier, you will be able to see all the regulatory documentation in the system.
Please contact Jacqueline Wong ([email protected]) or Nonny Jarvis ([email protected]) for customer access rights.
Please contact the regulatory documentation team ([email protected]) for documentation enquiries.
The confidentiality agreement defines the use of confidential information. Please consult your legal adviser.
For Accelerator Regulatory Dossier documentation, you can also consult your ACMS admin adviser [email protected].
Please send us an email to let us know who will be replacing whom. For ACMS/Accelerator Regulatory Dossier accounts, email . For all other subscriptions, email [email protected]. The new contact person must be registered for a Cytiva account before the subscriptions can be transferred. Note that it is possible to register a generic company email address.
Please create a new account. Then inform us of the change at ACMS/Accelerator Regulatory Dossier account, contact [email protected]. For all other documentation, contact [email protected].
Please note that it is possible to register a generic company email address.
Click Forgot password? on the login page.
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.
For ACMS/Accelerator Regulatory Dossier account subscriptions, contact [email protected]. For all other subscriptions, contact [email protected]
I have questions about the content of a specific Regulatory Support Documentation or Change Control Notification. Who do I contact?
For ACMS/Accelerator Regulatory Dossier support, contact [email protected]
For all other requests, find your local contact at www.cytiva.com/contact
To open Accelerator Regulatory Dossier PDF files in any internet browser instead of downloading them:
- Click the ‘VIEW’ button.
For all other PDF Files
To open PDF files in Firefox instead of downloading it:
- Open the menu on top right corner, and navigate to “Options”.
- Scroll to “Files and Applications” section of the “General” tab.
- In applications search for PDF Content Type, and select “Open in Firefox” action.
To open PDF files in Chrome instead of downloading it:
- Ensure that “Adobe Acrobat” or “PDF Viewer” Chrome extension is installed and enabled.
- Go by pass chrome://settings/content/pdfDocuments to “PDF documents” settings.
- Select “Download PDF files instead of automatically opening them in Chrome” then switch it to "Off".
Acrobat® is a registered trademark or trademark of Adobe in the United States and/or other countries. Google Chrome is a trademark of Google Inc. Firefox is a trademark of Mozilla Foundation. Pall is a trademark of Pall Corporation. Any other third-party trademarks are the property of their respective owners.
Historical documentation will remain accessible via the Accelerator Documentation Center homepage.
Validation Guides, Resources, SME (Subject Matter Expert) Corner, Instructional Documentation, and Accelerator Regulatory Dossier will continue to link directly to the original web locations. If you’re using the Accelerator Regulatory Dossier, you must register for an account here.
Regulatory Compliance Statements redirect to the Cytiva Regulatory Statements page.
Quality Documentation redirects to the Cytiva Quality Management page.
Product Batch Certificates redirect to the Cytiva Regulatory Support page.
To contact someone regarding product queries, please create or log in to your Cytiva customer account.
For further information regarding historical documentation, please contact us.
The Accelerator Regulatory Dossier application is the central point of access for product-specific regulatory and compliance documents for all individual components used to manufacture Allegro™ single-use systems. It provides comprehensive and up-to-date documentation, including product specifications, manufacturing information, validation documents, and compliance statements to support your risk assessment, regulatory submissions, and audits.
It also provides drawings via the drawing’s viewer.