Quality Management System implemented in accordance with applicable regulatory requirements.

Pharmaceutical compliance

• Applicable national regulatory requirements
• EU GMP-compliant manufacturing partners
• Batch release and certification procedures
• Pharmacovigilance system in place
• Regulatory submissions and lifecycle management

Medical Device compliance

• EU Medical Device Regulation (EU 2017/745)
• Technical documentation maintained
• Post-market surveillance system
• Vigilance procedures implemented
• Good Clinical Practice (GCP) and Good Laboratory Practice (GLP)

General

• Data protection regulations (GDPR)

We are committed to transparency, scientific
integrity, and responsible communication.