Quality & Compliance
Built on a Foundation of Uncompromising Quality
Every BioTical product leaves our facility having passed rigorous quality controls aligned with international standards.
ISO Alignment
Processes aligned to ISO 13485 Medical Device Quality Management System requirements and ISO 9001 principles.
GMP Principles
Good Manufacturing Practice embedded in every production step, from raw material intake to final product release.
Quality Assurance
Comprehensive QA programmes including incoming QC, in-process controls, finished product testing, and batch certification.
Traceability Systems
End-to-end lot traceability via electronic batch records, ensuring full recall capability and audit-readiness.
Validation Support
IQ/OQ/PQ documentation, analytical method validation, and assay performance verification for new products.
Regulatory Affairs
Guidance and dossier support for CE marking, WHO prequalification, FDA registration, and local market approvals.