Certifications & Accreditations
Validated quality credentials and supplier qualification support for biosafety and CMC testing programs.
Evidence for supplier qualification and audit planning
Certifications and accreditations help customers evaluate whether a testing partner has the quality-system discipline, technical scope, documentation control, and audit-readiness required for regulated biosafety and CMC testing work. HyQure should publish only claims that match current certificates, approved scopes, and QA-approved evidence.
ISO17025 Accreditation (CNAS)
Initial accreditation was achieved in 2022. Scope expansions and site additions were approved in both 2023 and 2025. The current scope covers nearly the entire field of biosafety testing, encompassing 30+ test items and standards.
ISO 9001 Certification
First certified to ISO 9001 in 2021by
by United Kingdom Accreditation Service (UKAS) and has successfully passed annual surveillance audits every year since.
EU QP GMP Declaration / GMP Compliance Statement
Laboratory Biosafety Testing sites given in Part A of the statement, comply with the principles and guidelines of good manufacturing practice.
BSL-2/Enhanced BSL-2 Certificated/BSL-3
- Human-derived pathogenic microorganisms BSL-2 laboratory
- Animal-derived pathogenic microorganisms BSL-2 laboratory
- Enhanced BSL-2 (BSL-2+) laboratory
- Collaborating BSL-3 Laboratory
Related HyQure services
Analytical Development & Validation
Plan a quality-driven testing package
Share product type, development phase, target market, sample type, method status, and expected report format. HyQure can help align scope, documentation, and timeline before project initiation.
Official regulatory reference links
- ISO17025 (CNAS) English
- ISO 9001:2015 Standard
- ICH Quality Guidelines
- MHRA GxP Data Integrity Guidance
- EU GMP Annex 11