To meet the rigorous standards of the global biopharmaceutical industry, we secure all necessary certifications and regulatory approvals required for the production and marketing of our products.
Our compliance framework includes:
IVD Certification
for diagnostic antibody products
Risk Management Systems
in line with international standards
Compliance with EU Regulations
supported by Notified Body assessments
Comprehensive Quality Management Systems
Product Performance Evaluation & Market Surveillance Systems
Ongoing Compliance Checks and Third-Party Certifications
These certifications ensure our products and services consistently meet the highest standards of safety, performance, and regulatory compliance.