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  

  • imageDr. Falk Pharma and Zedira announce successful completion of the phase 2a proof-of-concept study of ZED1227 for the treatment of Celiac Disease
  • imageDr. Falk Pharma und Zedira verkünden den erfolgreichen Abschluss der Phase 2a-Studie mit ZED1227 zur Behandlung von Zöliakie
  • imageReversibly acting transglutaminase 2 inhibitors: drug candidates for the treatment of fibrosis
  • imagePress release: Zedira announces ISO 9001:2015 certification

Blog  

  • imageDesign of Oral FXIIIa Blockers as Safer Anticoagulants – Mission Impossible?
  • imageMicrobial transglutaminase (MTG) enables efficient and site-specific conjugation to native antibodies without the need of antibody engineering

Events  

  • Gordon Research Conference: Transglutaminases in Human Disease Processes

    12.06.2022 - 17.06.2022
    Mount Snow, USA

  • 19th International Celiac Disease Symposium

    19.10.2022 - 22.10.2022
    Sorrento, Italy