Quality
Our commitment to quality
Our digital Quality Management System (QMS) and Document Management System (DMS) ensure excellence in laboratory procedures, reports and certificates.
Our state-of-the-art digital systems cover all facets of our operations, providing an integrated approach to managing documents and maintaining quality standards. This ensures transparency, traceability and compliance with regulatory requirements.
Laboratory operations
Streamlined processes for sample handling, testing and analysis.
Documentation
Centralized and secure document management to ensure accuracy and accessibility.
Reporting
Reliable and precise final reports and certificates that meet regulatory standards.
Global PATHOQUEST registrations/certifications
- GMP Certificates for our Paris site:
Our sites are Good Manufacturing Practices (GMP) compliant to guarantee the safety, quality and efficacy of our assays.
- FDA (Food & Drig Administration) Sites Registration:
Our two laboratories (US and France) are FDA registered. See our registrations on the FDA website.
- Manufacturing and Import Authorization (MIA):
Our site is registered with the French Medicines Agency (ANSM) as a pharmaceutical establishment, demonstrating our commitment to maintaining high standards in quality control activities.
Dedicated Viral safety expert review
The views expressed in this document are the opinion of the participating members of the Innovation Task Force and the experts, and may not reflect the opinion of the EMA scientific committees
- Expertise in virology for reliable testing services: Our team of scientific experts ensures that all our testing reports are virologically meaningful and reliable. With our extensive virology expertise, we guarantee that our assays meet the highest standards of accuracy and reliability.
- Agnostic assay support:
For our viral safety assays, every study report is systematically supported by a comprehensive virology expertise report.
Regulatory
Our iDTECT® NGS-based assays meet the highest regulatory requirements in biotesting, guaranteeing accuracy, reliability and compliance.
Ready to elevate your quality standards?
Contact us
France
+33 (0)1 70 82 17 90
Biopark -Bâtiment B,
11, rue Watt
75013 Paris, France
How can PathoQuest help?
U.S.
466 Devon Park Dr
Wayne, PA 19087
United States
France
+33 (0)1 70 82 17 90
Biopark -Bâtiment B,
11, rue Watt
75013 Paris, France
How can PathoQuest help?
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