Quality and regulatory support

Find key documents for audits, supplier qualification and compliance. Access change control notifications (CCN), regulatory statements, extractables data, and more.

Stay compliant and qualify with confidence

Whether you're qualifying Cytiva as a supplier or ensuring compliance with industry standards, this section provides access to quality and regulatory documentation — including change control notifications (CCNs), extractables data, regulatory statements, and quality management resources — to support audits, submissions, and help you confidently use Cytiva products.

Access to regulatory documentation

Explore both platforms to easily access technical and compliance documents that support audits, quality assurance, risk assessments, SOPs, validation and regulatory submissions.

Accelerator™ documentation center

Access regulatory and compliance documents related to single-use systems (SUS) and their components — currently supporting Allegro™ SUS and expanding. Documents include:

Product specifications
Manufacturing information
Validation documents & extractables reports
Compliance statements & reports
Technical drawings

Go to Accelerator™ documentation center

Regulatory support documentation portal

Subscription-based documentation for Cytiva customers working in regulated environments.  Stay updated with:

Change control notifications (CCN)
Regulatory support files (RSFs)
Validation guides (VG) & visual inspection guides
Validation support files (VSFs)
Extractables information (EI)

Access regulatory support portal

Stay compliant with our subscriptions

Explore subscription options in the regulatory support documentation portal to stay up to date with key changes.

Change control notifications

Purchased a Cytiva product? Access notifications about important updates to Cytiva products — including changes of manufacturing sites, critical subcontractors, raw materials, compliance status, or label and/or packaging materials.

Regulatory support documentation

Access documents to support compliance — including validation guides, regulatory support files and extractables data.

Documentation for supplier qualification

Quickly check and download essential quality and regulatory documents to help qualify Cytiva as a supplier.

Quality management

Find information on our quality management system and global site certificates such as ISO and more.

Explore quality management

Regulatory statements

Download Cytiva statements including animal origin statements, statements of compliance, allergen statements, and more.

View regulatory statements

Extractables and leachables

 Find extractables and leachables information to support product and process risk assessments.

Access extractables data

Certificates and safety data sheets

Product certificates

Search to find and download certificates (COA, COC, COQC, COI, COQ, COT).

Find product certificates

Safety data sheets

Find and download essential information on the safe handling, storage, and potential hazards of chemical products.

Search for safety data sheets

HyClone™ certificates and SDS

Search and download HyClone certificates and safety data sheets (SDS).

Access HyClone documents

Security and sustainability at Cytiva

Security of supply

Helping customers reduce supply chain risk, build resilience, minimize raw material variability.

Sustainability

We aim to make a difference to our customers and the impact we have on society and the environment.

Regulatory services consulting

Navigating global regulatory requirements can be complex — but you don’t have to do it alone. Whether you're preparing your first clinical submission or managing post-approval compliance, our experts are here to guide you. From strategic consulting to document publishing and lifecycle support, we help you move forward with clarity and confidence.

Explore our regulatory services

Need support with regulatory documents?

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Frequently asked questions

Are Pall and Cytiva the same company?

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.

What is the difference between the notifications related to RSF/VSF/VG and CCN?

Subscribers to regulatory support documentation receive notifications pertaining to changes in the content of the regulatory support documentation. Change control notification (CCN) subscribers receive notifications pertaining to changes associated with the manufacture of products in accordance with our standards.

Read more about how we work with CCNs here.

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