Regulatory support documentation
Access free regulatory documents with automatic updates — for validation, SOPs and compliance.
Documentation that supports every step
Regulatory support documentation is essential for process development, validation, standard operating procedures (SOPs), and regulatory submissions. With a free Cytiva account, you can access key files — including regulatory support files (RSFs), validation guides (VG), extractables summaries, and more — and subscribe to receive updates when new versions become available.
How to get started with regulatory documents
- Register or log in with company email address (use a generic company email to maintain change continuity).
- Go to the regulatory documentation section and accept the confidentiality agreement if prompted.
- Find the documents you want to access and monitor.
- Subscribe to stay informed — you'll receive email notifications whenever updates are published.
Explore regulatory document types
Find out what each document covers and how it supports compliance and product safety.
Regulatory support files (RSF) for chromatography resins
Get detailed information on performance, stability, extractable compounds, and analytical methods for chromatography resins.
The RSFs contain product information such as:
- Product description providing information on product characteristics, a reference spectrum, and links to support materials such as safety data sheets (SDS),
- Product quality including a statement on animal origin, analytical specifications and test methods as well as a certificate of analysis example,
- Manufacturing description covering a description of the facilities, a brief overview of the manufacturing process, and information on raw materials and container materials used,
- Product stability containing, for example, results from chemical stability testing, compatibility with expected process conditions, stability at recommended CIP protocol, and information on shelf life,
- Extractable compounds providing information on residual solvents and clearance of shipping solution as well as an assessment of possible degradation products,
- Toxicological information including results from toxicological studies. This is sometimes replaced with a theoretical risk assessment based on data from leakage studies.
Looking for additional documentation for Allegro™ single use systems?
Access the Accelerator™ documentation center to find information needed to support audits, risk assessments and regulatory submissions - currently supporting Allegro™ single-use consumables and expanding.
Related regulatory resources
Frequently asked questions
What is a regulatory support file (RSF)?
A regulatory support file (RSF) 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.
What is a validation guide (VG)?
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.
What is a validation support file (VSF)?
Validation support files (VSF) 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.
What is the difference between regulatory support file (RSF) and drug master file (DMF)?
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.
Can I share information contained in RSF/VSF/VG/Accelerator™ documentation center documents?
The confidentiality agreement defines the use of confidential information. Please consult your legal adviser.
For Accelerator™ documentation center documentation, you can also consult your ACMS admin adviser ACMS-doccontrol@cytiva.com.
I have questions about my subscriptions. Who do I contact?
You can view our short instructional presentation that explains how document access and subscriptions work. View the presentation.
For ACMS/Accelerator™ documentation center account subscriptions, contact ACMS-doccontrol@cytiva.com. For all other subscriptions, contact RegulatorySupport@cytiva.com