On February 8, Ukrainian Darnitsa Pharmaceutical Company reported that it became a member of The Regulatory Affairs Professionals Society (RAPS). The company's press service informs that it is the largest global organization of professionals involved with the regulation of healthcare and related products (pharmaceuticals, medical devices, biologics and nutritional products) with headquarter in the United States near Washington, D.C. and with offices and affiliates around the world.
Founded in 1976, RAPS is a non-profit organization that develops professional standards in the field of regulation, conducts research, promotes the exchange of knowledge and networking, and carries out Regulatory Affairs Certification.
“In the context of the extraordinary situation in the global healthcare system caused by the COVID-19 pandemic, regulatory professionals in all countries have faced new challenges. RAPS has the necessary resources to address them, and new opportunities have opened for Darnitsa to improve professional competencies in this area upon joining the global network. We have received additional tools to increase the availability of safe and effective pharmaceuticals, in particular, by raising standards of work in the regulatory sphere,” said Oleksandr Torhun, Darnitsa’s Director of Regulatory Affairs.
He noted that as part of its participation in RAPS the company plans to focus on improving and raising standards for documents preparation, performance of clinical trials, quality assurance and market access of drugs, as well as monitoring of their administration.
Darnitsa Pharmaceutical Company was founded in 1930. There are about 280 medicines and substances in the company’s portfolio. The beneficiaries of the company are the Zagoriy family.