Quality & Compliance for Global Biosafety and CMC Testing
Quality-driven biosafety and CMC testing support for biologics, vaccines, viral vectors, and cell and gene therapy programs moving across international development pathways.
Quality systems that support regulatory-facing biosafety data
Quality Management System (QMS)
Controlled procedures, training, equipment lifecycle, material control, method validation/verification, deviation, CAPA, change control, internal audit, and management review.
Regulatory Alignment & Guidelines
Testing strategies mapped to ICH, WHO, FDA, EMA, NMPA/CDE, PMDA, MHRA, TGA, Health Canada, MFDS, CDSCO, and HSA expectations where relevant.
Certifications & Accreditations
Certificate and scope information for supplier qualification. Exact dates, scopes, logos, and claims must match QA-approved evidence before publication.
Data Integrity & Digital Systems
ALCOA+ principles, LIMS/EMS/e-signature controls, CSV, audit trails, access control, backup/recovery, and QA review for regulatory-facing data.
HyQure service focus
Cell line characterization, viral clearance, RCL/RCR/rcAAV testing, adventitious agent testing, mycoplasma and sterility, lot release and stability, residual DNA/RNA/HCP/process residue testing, and GMP/GLP-supportive reporting.
Why this is competitive internationally
International customers qualify testing partners based on evidence, not decoration. HyQure should present concise quality proof, direct service links, regulatory-aware language, and official references so QA/QC, CMC, regulatory, and procurement teams can evaluate HyQure quickly.
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
- FDA 21 CFR Part 58
- FDA 21 CFR Part 210
- FDA 21 CFR Part 211
- FDA 21 CFR Part 11
- EU GMP Annex 11
- WHO GMP Guidelines
- ICH Quality Guidelines
- ISO/IEC 17025:2017 Standard
- ISO 9001:2015 Standard