Access quality documents
Find foundational documents that define Cytiva’s approach to quality and compliance — supporting regulated workflows and supplier qualification.
Quality management
Access essential quality and compliance documentation — including certifications — to support audits, regulatory submissions, and supplier qualification in GMP environments.
Quality you can trust
At Cytiva, quality isn’t just tested — it’s built into everything we do. From design to manufacturing, every product must meet strict standards and deliver high performance.
With over 50 years in biotechnology, we offer trusted technologies, services, and regulatory support for products used in regulated environments. Our consistent supply to the biopharmaceutical industry reflects our commitment and capability.
To request a customer audit, contact your local Cytiva representative.
Global site certificates
Find certifications for Cytiva’s manufacturing sites that verify compliance with international standards.
ATEX certificates
CE EC certificates
HALAL certificates
ISO 13485 certificates
- Cytiva ISO 13485:2016 Cardiff
- Cytiva ISO 13485:2016 Dassel
- Cytiva ISO 13485: 2016 Fribourg, Switzerland - Pall Medical
- Cytiva ISO 13485:2016 Logan
- Cytiva ISO 13485:2016 New Zealand
- Cytiva ISO 13485:2016 Pasching
- Cytiva ISO 13485:2016 Singapore
- Cytiva ISO 13485:2016 Sweden AB
- Cytiva ISO 13485:2016 Tonglu
- Certificate of Approval: Pall Newquay , Pall Manufacturing UK Limited
- Certificate of Approval: Pall Puerto Rico
ISO 22301 certificates
ISO 3834 certificates
ISO 45001 certificates
ISO 50001 certificates
ISO 9001 certificates
MDSAP certificates
Pressure Equipment Directive 2014/68/EU certificates
Pressure Equipment Safety Regulations, UK Statutory Instruments No 1106
EHS program management
Cytiva is committed to having a world-class program for managing environmental, health and safety (EHS) risks. The commitment begins with our board of directors, which regularly reviews the company’s environmental, health and safety performance. Cytiva's vice president for EHS sets and implements the EHS strategy.
See certification and policy documents:
Danaher EHS Policy
ISO 14001:2015 Certification
Related regulatory resources
Frequently asked questions
How do I change the contact person for a RSF/VSF/VG/Accelerator™ documentation center or CCN?
Please send us an email to let us know who will be replacing whom. For ACMS/Accelerator™ Regulatory Dossier accounts, email acms-doccontrol@cytiva.com. For all other subscriptions, email regulatorysupport@cytiva.com. 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.
Do I need a confidentiality agreement?
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 (jacqueline.wong@cytiva.com) or Nonny Jarvis (nonny.jarvis@cytiva.com) for customer access rights.
Please contact the regulatory documentation team (ACMS-doccontrol@cytiva.com) for documentation enquiries.