Clinical trials are conducted with an aim to obtain sufficient results for determining the efficacy and safety of a drug in humans. These studies are an important step on the way to receiving a marketing authorisation of a medicinal product, providing evidence for benefit-risk assessment.
Every year, the company carries out various clinical studies (bioequivalence, efficacy, safety studies) in several countries in accordance with the applicable EU and national laws following the Guidelines for Good Clinical Practice (GCP).
Director of the Department of Medicine and Regulatory Affairs
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