Medicinal products
If you can’t describe what you are doing as a process, you don’t know what you’re doing.” | W. Edwards Deming
SUPERA KVALITETA provides business consulting services in the field of medicinal products for the implementation, maintenance and improvement of:
- Good Manufacturing Practice – GMP
- Good Distribution Practice – GDP
- Good Laboratory Practice – GLP
- Good Clinical Practice -GCP
- Good Pharmacovigilance Practice – GVP
- Good Automated Manufacturing Practice – GAMP
- Quality Management System – QMS
Our activities also include project planning and their regular review, support during product development and portfolio management, design for renovated or new facilities (laboratories or pharmaceutical manufacturing facilities), as well as support during the development and validation of computer systems (SDLC), data integrity, and compliance with GAMP. We are able to train staff at all levels of the organization and interact with them, establish and motivate teams to process improvements and lead company-wide programs that result in significant cost reductions. With our help, our clients have successfully implemented and improved their quality system, aligned it with Good Practice Requirements (GxP) and received approvals or certifications from regulatory bodies such as the Ministry of Health of Republic of Croata, US FDA, EU, PIC / s and WHO.
We also perform internal audits and third-party audits in compliance with applicable regulatory requirements and standards. We organize and perform in-house trainings in English language for GxP, risk management, internal audit performing and other topics in the field of medicinal products.
Since 2013, we have been actively supporting a large number of established and newly established pharmaceutical wholesalers in establishing and improving their quality management systems and ensuring compliance with national laws and regulations governing the wholesale distribution of medicinal products, as well as with the EU GDP Guidelines. We have conducted more than 200 seminars covering a wide range of topics related to the wholesale distribution of medicinal products, attended by several thousand participants. We continuously provide training for Responsible Persons (RP) responsible for the wholesale distribution of medicinal products. For more information about our seminars, please see our seminar schedule.
With our support, our clients have successfully implemented and improved their quality management systems, brought them into compliance with Good Practice (GxP) requirements, and obtained approvals or certificates from regulatory authorities such as the Croatian Ministry of Health, the Croatian Agency for Medicinal Products and Medical Devices (HALMED), EU GMP regulatory agencies of EU Member States, pharmaceutical inspectorates in countries across the region, the U.S. FDA, PIC/S and WHO.
Users of our business consulting services, as well as participants in our pharmaceutical-related seminars, come from Croatia, Slovenia, Bosnia and Herzegovina, Serbia, North Macedonia, Montenegro, Ukraine, the Czech Republic, Switzerland, the United Kingdom, France, Malta, Cyprus, Türkiye, India and Cuba.
We conduct internal audits as well as third-party audits in accordance with applicable regulatory requirements and standards.
For companies headquartered outside the EU (companies established in third countries), we offer representation services in the process of obtaining an EU GMP certificate issued by the Croatian Agency for Medicinal Products and Medical Devices (HALMED).
You can learn more about Good Practices and pharmaceutical regulations, internal audits conducting, risk management, and other topics related to the manufacture, quality control, storage and wholesale distribution of medicinal products through our in-house seminars, which can be fully tailored to your specific needs. Information about our open-enrolment seminars can be found in our seminar schedule.
