Regulatory Strategy
The Regulatory Affairs Department’s primary objective is to enhance our product portfolio by researching regulatory strategies that align with existing laws and regulations, along with the highest compliance standards. We strive to offer our partners current regulatory information, helping them navigate local requirements for the matters overseen by this department, including:
Comprehensive regulatory services, encompassing the registration of both pharmaceuticals and medical devices
Thorough validation and follow-up procedures for application files to secure product approvals and enable market entry
Ongoing management of existing registrations, including renewals and variations
Keeping partners informed about relevant legal and regulatory updates
Offering support in market research activities, such as product evaluation, market capacity assessment, and competitive analysis
We keep ourselves informed about regulatory changes by regularly monitoring the official website of the National Agency of Medicines and Medical Devices: akbpm.gov.al.
