RESEARCH AND DEVELOPMENT
By opening the Research and Development Institute, Alkaloid AD Skopje confirmed its dedication to producing high-quality, safe, and efficient drugs and its commitment to continuous development. This unique, highly sophisticated unit, the first of its kind in the country, was officially launched on 11 March 2009.
For more than a decade, the Alkaloid's R&D Institute is recognised as a research unit that introduces new products, technologies, analytical methods, and services, thus ensuring a reach product portfolio. At the same time, it cares about the environment and health and safety at work.
The Institute occupies an area of 1.540 square meters. Equipped with state-of-the-art laboratory and pilot production equipment, it allows for the development of new and modern forms of generic drugs based on the latest achievements in pharmaceutical science.
The establishment of the R&D Institute was of great importance for the development of new technologies and analytical methods, including higher quality standards, continuous improvement, and fulfilment of the strictest 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 for the activities of each unit.
The Feasibility, New Product Development, Technical Operations, Scientific Excellence, Clinical Trials Unit, Quality Unit, and Intellectual Property operational segments define the scope of activities of the R&D Institute.
The process starts with feasibility, intellectual property, and patentability assessment of all new products. Next is the formulation and new drug development, in-vivo testing in clinical trials, transfer to production, followed by process validation assessment and stability monitoring program.
The R&D Institute recruits highly qualified staff and supports them with the necessary project management resources at all levels. It employs more than 150 highly specialized, trained, and qualified people.
The R&D Institute aims at delivering safe and efficient drugs compliant with the regulatory requirements and the company's corporate policy - Health Above All!
The values promoted by the individual dedication of each Institute's employee strengthen the support for achieving of the jointly set goals !