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Darnitsa Sped Up the Drug Development Process

03 March 2020

In 2019 Darnitsa digitalized drug master files. This was made possible by the introduction of an information system based on the SAP / OpenText product platform. Thus, Darnitsa is one of the first pharmaceutical companies in Ukraine to implement electronic document flow to create drug master files in accordance with the EU and US pharmaceutical standards.

Digitalization of the processes of development, registration and manufacturing of pharmaceutical products is a key element of Darnitsa's growth plan. It provides reliability in the storage, access and integrity of information. The introduction of the electronic drug master file opens up new opportunities for Darnitsa. Now the company creates ready-made content for regulatory reporting according to the requirements of state regulators of other countries.

Andrii Obrizan, CEO:

“We have invested over € 1 million in the creation of a digital eco-system for the life cycle of medicines. It is a key element of Darnitsa's growth plan and its transformation into an international brand. With SAP and OpenText solutions implemented, we have improved the quality control of our manufacturing systems and gained competitive advantages in pharmaceutical development and manufacturing processes, efficient project management and ensuring the integrity of change management processes, and streamlined the product registration procedure in order to enter new markets”.

The significant challenge was to choose among the existing variety of technological solutions the one that would meet the objectives of the project. The selection was based on an analysis of technologies that could ensure the work with heterogeneous content, lifecycle management of such content and no compromise security in accordance with world standards and best practices. Requirements to the supplier were not only limited to the availability of the technology, but also required relevant experience in the pharmaceutical industry.

This combination of requirements ensured the successful implementation of the integrated solution and narrowed the range of potential partners. It is the experience of SAP / OpenText in the pharmaceutical industry in the implementation of such projects that has determined them as Darnitsa's technology partners.

Maksym Matiash, Director of SAP Ukraine:

“We have been successfully cooperating with Darnitsa since 2013, implementing SAP technology solutions to improve the efficiency of all business processes and helping the company to develop in line with the highest global standards. Through the use of SAP ECM by OpenText, Darnitsa has built a holistic and integrated system that not only minimizes time and error in the preparation of the electronic drug master file, but also ensures compliance with the regulatory requirements of other countries relating to management of the drug life cycle. Due to this, our partner will be able to expand the sales territory in such strictly regulated markets as the EU and the US”.

Andrii Romanеnko, CIO:

“The technical scalability of the platform from SAP and Open Text will make it possible to store large amounts of content. This is in line with our goals of creating a future content management platform for other related business processes that are outside the scope of this project. In the next phase, we plan to improve production processes, interaction with partners and contractors, in particular, incorporate back-office processes (procurement, personnel management, etc.) to create an efficient paperless ecosystem in Darnitsa.”

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