The “Darnitsa” Company has become a member of RAPS – Dmytro Shymkiv

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  • Darnitsa’s permeative striving for improvement has manifested itself in the paperwork as well. Now the company is focusing on enhancing the standards for preparing the documents, conducting clinical trials, sustaining the quality and releasing the medicines on the market and monitoring the way they are being used.

    The pharmaceutical company “Darnitsa” has become a member of  RAPS – The Regulatory Affairs Professionals Society – the world’s largest organisation of professionals specializing in regulating the healthcare system and related products (medicinal products, medical devices, biological and food products). RAPS has headquarters in the United States near Washington and offices and subsidiaries around the world. Founded in 1976, RAPS is a non-profit organization that develops regulatory professional standards, conducts research, promotes knowledge sharing and networking, and provides regulatory certification (RAC).

    According to Dmytro Shymkiv, being a participant of the global network, the corporation plans to concentrate on improving and raising the standards for preparing documentation, conducting clinical trials, ensuring the quality and admission of medicines onto the market and monitoring their use.

    The global health emergency caused by the COVID-19 pandemic has confronted the regulatory professionals in all countries. RAPS has the resources to weather this challenging moment. Having joined this global network, Darnitsa has opened up new opportunities for improving professional competencies in this area. Due to the increased standards of work in the regulatory sphere, the Ukrainian pharmaceutical concern received additional tools to make safe and effective medicines more accessible.

    Despite the tough times, Darnitsa Group continues to actively invest in new research and development. Moreover, the pandemic has given impetus to the implementation of projects that earlier were only discussed. Now the pharmaceutical company “Darnitsa” is systematically introducing the latest IT technologies into its production, working on increasing the number of in silico studies, that is a computer modeling of biological experiments. All these efforts will allow us to make fast and more accurate predictions of the consequences of diseases and the outcome of therapy.  This means that the pharmaceutical industry will be able to produce new, much more effective drugs with fewer side effects.


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