05. November 2019

Press release: Zedira announces ISO 9001:2015 certification



Darmstadt, November, 5th 2019

Zedira is proud to have been awarded ISO 9001:2015 certification, one of the most rigorous and well-regarded standards in the world.
Diagnostic and pharmaceutical industries are subject to increasing regulatory demands.
Zedira is a provider of raw materials and services for said industries. Zedira’s decision to implement the management system as per DIN EN ISO 9001:2015 demonstrates its commitment to continually improving its products and services. The internationally recognised standard ensures Zedira’s products and services meet the needs of customers through an effective quality management system.

To become ISO 9001:2015 compliant, the entire Darmstadt (Germany) based Zedira team, underwent an extensive company-wide audit by TÜV Hessen, according to "TÜV PROFiCERT" procedures. The certificate was presented on September 13th, 2019 with the scope “research, development, production, and distribution in the area of biotechnology”.


About Zedira GmbH:
The Darmstadt-based biotech company has a focus on celiac disease and other transglutaminase-linked conditions in the arena of autoimmunity, fibrotic disease and coagulation. The company develops, produces and markets specialty reagents and kits for research and development as well as for clinical diagnostics. Zedira further produces microbial transglutaminase (MTG) as raw material for antibody drug conjugate (ADC) production.
Zedira established a pipeline of drug candidates adapted to specific indications based on its patented family of low-molecular transglutaminase blockers. ZED1227 is the first direct acting transglutaminase inhibitor in clinical development. The small molecule tissue transglutaminase blocker is currently in Phase 2a clinical trials for the treatment of celiac disease together with Dr. Falk Pharma.
Zedira is a portfolio company of the German High-Tech Gründerfonds.

Download Certificate
Z190913-english.pdf (English Version)
Z190913-deutsch.pdf (German Version)


Document

Products

  • Zedira offers a huge portfolio of reliable specialist transglutaminase related products meant to catalyze research and development, both in academia and industry.

News  

  • imagePress release: Zedira announces ISO 9001:2015 certification
  • imageZedira communication: Joint poster presentation on “Feasibility of a new automated FXIII activity assay”
  • imageArtikel in DZG Aktuell 01/2019 über die klinische Wirksamkeitsstudie unseres potentiellen Zöliakie Medikaments (deutsch)
  • imagePreview: Catalogue Editorial 2019
  • Press release: Dr. Falk Pharma and Zedira announce start of the phase 2a proof of concept study of ZED1227 for the treatment of celiac disease
  • Artikel in DLG-Lebensmittel – 06/2017 zur Bestimmung von Transglutaminase in Lebensmitteln (deutsch)
  • Zedira publication: Microbial Transglutaminase Used in Bread Preparation at Standard Bakery Concentrations Does Not Increase Immunodetectable Amounts of Deamidated Gliadin
  • Pressemitteilung: Dr. Falk Pharma und Zedira geben den Abschluss der Phase 1b-Studie für ZED1227 zur Zöliakie-Therapie bekannt und planen Start der Wirksamkeitsstudie
  • Press release: Dr. Falk Pharma and Zedira announce completion of phase 1b clinical trial of ZED1227 for the treatment of celiac disease and move on to proof of concept study
  • Press Release: Dr. Falk Pharma GmbH and Zedira enter a phase 1b clinical trial for a celiac disease drug
  • Zedira publication: Microbial transglutaminase has a lower deamidation preference than human tissue transglutaminase on a celiac disease relevant wheat gliadin T-cell epitope
  • Press release: Additional subsidy funding for clinical development of a celiac disease drug
  • Pressemitteilung: Zusätzliche Fördermittel für die klinische Entwicklung eines Zöliakie-Medikamentes
  • Press Release: Cooperation between Zedira and Cardiff University - Transglutaminase 6 is the focus of new research into ataxia
  • Press Release: Dr. Falk Pharma and Zedira enter phase I clinical trials for a celiac disease drug
  • Press release: Zedira receives further funding to develop Factor XIIIa-blockers for safe anticoagulation

Blog  

Events  

  • New Frontiers Symposium

    23.11.2019
    Chicago, USA

  • World ADC London 2020

    02.03.2020 - 05.03.2020
    London, Great Britain

  • Celiac Disease Center's International Symposium

    06.03.2020 - 07.03.2020
    New York, USA

  • Gordon Research Conference - Transglutaminases in Human Disease Processes

    14.06.2020 - 19.06.2020
    Mount Snow, USA

  • Tampere Celiac Disease Symposium 2020

    18.09.2020 - 19.09.2020
    Tampere, Finland