Compliance

Our products meet the highest ethical and legal standards. We comply with European biomedical conventions, respecting human rights and donor privacy. And we’re committed to quality, whether that’s in our products, or the training and customer service that support them.

Our commitment to quality

To do great research, you need high-quality products you can trust. That’s why we’ve put quality and reliability at the heart of our business for over 30 years.

Our portfolio includes over 7,000 cell culture and cell biology products. Each is rigorously tested, and designed to meet the demands of cutting edge research.

This commitment to quality extends to our service. We see our customers as partners, and we want to give them the support they need to do groundbreaking work – whether that’s everyday customer support, detailed technical help, or training that empowers them to do more.

For us, quality is never optional.

Quality Policy

Our quality policy is underpinned by four key premises:

  • Provide high-quality reliable products
  • Maintain a high ethical standard
  • Support customized requirements
  • Continuous improvement & development

To learn more, download our Quality Policy Statement

ISO 9001:2015 certification

Our ISO certifications demonstrate our commitment to quality.

ISO 9001:2015 certification ensures that we “consistently provide products and services that meet customer and applicable statutory and regulatory requirements”.

Download certificate:

ISO 9001:2015 certificate

EXCiPACT™ GMP Certification

Our Quality Management System is also certified according the EXCIPACT™ GMP standard. This certification also covers the GMP requirements according to NSF/IPEC/ANSI 363.

We produce our cell culture media and reagents using the highest standard of raw materials to ensure their quality when used as pharmaceutical excipients. They are manufactured in adherence to GMP standards as published by IPEC (International Pharmaceutical Excipients Council) in the Joint Good Manufacturing Practice Guide for Pharmaceutical Excipients.

Download certificates:

EXCiPACT™ certificate
ANSI 363-2016 certificate

Ethical standards

All our products meet the strictest European and international ethical standards.

We comply with the following best-practice procedure for human tissue donation and collection:

The tissue used by PromoCell for the isolation of human cell cultures is derived from donors who have signed an informed consent form (this being done by the donor himself, an authorized agent, or a legal agent) which outlines in detail the purpose of the donation and the procedure for processing the tissue. We do not accept or use any tissue without prior signing of the consent documents.

Our procedure always meets these international standards:

If you have any questions about the quality and ethical standards of our products, please get in touch.

Contact person:

Dr. Irma Börcsök
Phone: +49 6221 – 649 34 0
Fax:       +49 6221 – 649 34 40
ethics@promocell.com

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