Regulatory Affairs, Compliance & Quality

Galinos Pharm offers regulatory support for the registration and lifecycle management of medicinal products in North Macedonia, Serbia and Kosovo, coordinating submissions, variations and ongoing maintenance.

Our quality system follows recognized international standards including GDP principles, EU GDP guidance and FMD measures, as well as WHO GDP recommendations and local regulations

From qualification of suppliers to release of deliveries, every step is documented and audited to ensure product integrity and patient safety.
We also maintain local pharmacovigilance systems, for continuous safety monitoring and relevant reporting to regulatory authorities.