Regulatory affairs and pharmacovigilance

We are complementing our key product groups and accelerating our entry into new therapeutic areas by developing and registering new and upgraded products.

In the New Products department, we introduce new products and manage those already available in the market. We oversee projects from idea through the development phases to marketing authorisation and market launch, ensuring the competitiveness and safety of products on the market.

Medical Research and Pharmacovigilance deals with the clinical use of human and veterinary medicines. We frame concepts for new product development, evaluate the clinical efficacy and safety of products, plan and conduct clinical trials, prepare product efficacy and safety registration dossiers, evaluate adverse reactions, and plan activities to ensure the safe use of medicines throughout their lifecycle – from concept to new product development and while the product is on the market.

In Regulatory Affairs, we prepare registration dossiers that need to be aligned with the requirements of each market, obtain and maintain marketing authorisations for products throughout their lifecycle in all markets, prepare registration strategies for the filing of new product marketing authorisations, renewals and variations, and manage the registration process. In our work, communication with regulatory authorities in each country and monitoring regulatory changes in all markets are key to obtaining and maintaining registrations within the expected timelines.

Learn about work on new products directly from Krka employees.