Pharmaceutical services

Provision of pharmaceutical regulatory services, including:

• Strategic and regulatory advice for national / international issues in the area of pharmaceutical and medicinal products;
• identification and performance of appropriate application procedures related with the respective Albanian institutions regarding pharmaceutical and medicinal products;
• Evaluation of regulatory or other documentation concerning the Albanian legislation currently into force;
• Compilation of a complete marketing authorization (MA) dossier, in order to receive a MA in the Republic of Albania;
• Regulatory and commercial compliance regarding medicinal products concerning applicants;
• Preparation and attendance at meetings with the Albanian authorities (pre-submission meetings, scientific advice);
• Market studies concerning pharmaceutical and medicinal products.”