RESEARCH AND DEVELOPMENT
By establishing the Research and Development Institute, Alkaloid AD Skopje reaffirmed its dedication to manufacturing high-quality, safe, and efficient drugs, thereby demonstrating its commitment to continuous development. This unique and highly advanced unit, the first of its kind in the country, was officially put into operation on 11 March 2009.
For over a decade, Alkaloid's R&D Institute has been recognised as a leading segment dedicated to the research and development of new products, technologies, analytical methods, and services, thus ensuring a diverse product portfolio. Simultaneously, it prioritizes environmental protection and ensures occupational health and safety.
The Institute occupies an area of 1,540 square meters. Equipped with state-of-the-art laboratory and pilot manufacturing equipment, it allows for the development of new and modern forms of generic drugs and value added medicines based on the latest achievements in pharmaceutical science.
The establishment of the R&D Institute was of great importance to the development of new technologies and analytical methods, including higher quality standards, continuous improvement, and fulfilment of the most stringent requirements of all relevant regulatory authorities.
The R&D Institute consists of several departments, which allow for an efficient and successful implementation of the R&D quality assurance system, including quality standards specific to the activities of each unit.
The New Product Development, Technology and Process Development, Scientific Excellence, Clinical Trials Unit, Quality Unit, and Patents & Data Exclusivity operational segments define the R&D Institute’s scope of activities.
The processes start by assessing feasibility, freedom of action regarding patents and data exclusivity, and patentability of all new products, while monitoring the new drugs’ formulation development, their in-vivo testing through clinical trials and transfer to manufacturing. This is followed by process validation and stability monitoring activities.
The R&D Institute recruits highly qualified staff and supports them with the necessary project management resources at all levels. It has a workforce of over 150 highly specialized, trained, and qualified individuals.
The R&D Institute aims at delivering safe and efficient pharmaceuticals in line with regulatory requirements and the company's corporate policy - Health Above All!
The values promoted by the individual dedication of each Institute's employee further support the fulfilment of our commonly set goals!