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.
Founded in 2006, TBI CONSULTING is a management consulting firm that researches, develops, implements, operates and manage, environmental, health and safety projects and business solutions. We are particularly experienced to offer and deliver valuable advice that best suits to our customer needs based on requests and demands of our customers.
Address: Street “Ibrahim Rugova”, “Sky Tower”, Business Center, Floor 10, Office 103, Tirana, Albania