Certifications & Regulatory Compliance

Certifications & Regulatory Compliance

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

IVD Certification

for diagnostic antibody products

Risk Management Systems

Risk Management Systems

in line with international standards

Compliance with EU Regulations

Compliance with EU Regulations

supported by Notified Body assessments

Comprehensive Quality Management Systems

Comprehensive Quality Management Systems

Product Performance Evaluation & Market Surveillance Systems

Product Performance Evaluation & Market Surveillance Systems

Ongoing Compliance Checks and Third-Party Certifications

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.