According to the decision of the management of RegInfo, the system of ISO 9001:2015 is implemented, maintained and developed in the following fields:
- publishing, legalization, pharmacovigilance and documentation of medicines, medical devices and food for special medical purposes
- supporting implementation and operation of regulatory databases
- provision of IT security expert services.
Employees of RegInfo are also involved in the development of the quality system.
The executive manager declares a commitment to the system introduced by this declaration and has the employees follow this commitment.
The management and the employees of RegInfo monitor the scope of the quality management system in the environment of the organization, taking into account the essential requirements of the stakeholders and their impact on the operation of the organization. The company carries out its activities, in all respects, in compliance with the local and EU legal requirements.
RegInfo organizes its activities by identifying and analyzing risks and opportunities to meet all requirements. Clear tasks and responsibilities are created for the employees serving the needs of the stakeholders.
With its partners, RegInfo strives for a long-term relationship, thus paying attention to the exact and complete fulfillment of their needs to enhance their satisfaction.
Kollár Zsuzsa, managing director