Quality & Regulatory
CUSTOMER CHALLENGE
Finding a suitable expert partner to assist with your GMP biosafety testing and characterization needs is critical as these tests often form the bottleneck for release of product to patients.
With the iDTECT® platform of Quality Control (QC) assays, we provide cGMP and fully validated NGS-based testing methods, from sample preparation and bioinformatics analysis to actionable reports, according to the ICHQ5A(R2), ICHQ5B, ICH Q2(R2) and Q14 international guidelines.
PathoQuest is the trusted Quality Control (QC) supplier for many biotech/pharmaceutical companies navigating IND/IMPD projects and BLA/MAA authorizations.
OUR MISSION FOR QUALITY
At PathoQuest, we are committed to maintaining the highest standards of quality and compliance. Whether it’s ensuring the safety of the biologics products of our clients or adhering to regulatory requirements and/or guidelines, we take every step to meet and exceed industry requirements:
Replacement of animal-based models according to the 3Rs recommendation
GMP and validated methods
Global operations with 2 mirror GMP sites in EU and US with common methods, tools, digital infrastructure, and Quality System: Paris (France) and Wayne (PA)
Bioinformatics and IT infrastructure in compliance with 21 CFR part 11 and Annex 11
Submissions to Regulatory Agencies (FDA, EMA)
Our robust quality system, regulatory compliance, and adherence to GMP standards enable a straightforward adoption of our assays.
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“ The mission of PathoQuest is to ensure compliance and safety. We strive to de-risk the product development pipeline by preventing adventitious agent contamination and misidentification of cell lines.
Our NGS assays, available in both non-regulated and regulated environments, empower us to deliver high-quality results to our global customers.”
Sébastien Renouf (PharmD) | Chief Pharmaceutical Officer & Qualified Person | Pathoquest
Meeting the highest standards of quality and ensuring we comply with the latest regulatory requirements is at the heart of everything we do. Visit the two pages below to learn more about our quality and regulatory commitments.
Quality
Quality is at the core of our operations. Our digital Quality Management System (QMS) and Document Management System (DMS) ensure excellence in laboratory procedures, reports and certificates.
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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