The Regulatory Affairs Department aims to expand the company’s product portfolio through the development and implementation of regulatory strategies in full compliance with applicable legislation and international standards.

Our services include:

• Regulatory support for the registration of medicines and medical devices
• Review and verification of regulatory dossiers prior to submission
• Management of renewals, variations, and post-approval obligations
• Monitoring and communication of regulatory and legislative changes
• Support with market assessments, including product evaluation and competitive analysis

For regulatory updates, we rely on the official website of the National Agency for Medicines and Medical Devices (AKBPM) www.akbpm.gov.al