Pharmacovigilance
COOPER SA has a well-equipped analytical laboratory (Physicochemical-Biological-Microbiological) that meets the requirements of cGLPs, in which exercises strict control over all stages of the production process from raw ingredients and packaging materials, in-process controls, to the final product.
COOPER SA follows written procedures drawn up in accordance with international standards and GMP guidelines, as well as the ISO 9001:2015, ISO 13485:2016, standard and supervises all production processes as well as the reliability of installations, equipment, systems and all testing and production proceedures.
It also applies the principles and guidelines governing correct practice for storage and distribution of Medical Products and Devices, in accordance with Ministerial Decision DY8/1348/2004, and holds the relevant certificate from the competent certification agency, the Research Center for Biomaterials (EKΑPTY SA).
COOPER SA collects and monitors the safety data for all medicinal products marketed, in accordance with the guidelines governing Pharmacovigilance internationally.
For any report of an adverse event/reaction or a quality complaint about a COOPER SA product you can call at +30 2103462108 or send an email to the following address:
pharmacovigilance@koper.gr
For the needs of pharmacovigilance, the company collects personal data, based on the current legislation related to the safety of medicines. Data is stored for a period defined in the current legislation. Sending information or personal data to the above-mentioned email address, indicates your consent about data processing.
For FRESENIUS KABI products you can call at +30 210 6542 909 or send an email to the following address: FKHinfo@fresenius-kabi.com
Our objective in Cooper Pharmaceuticals is to ensure that every product, meets customers and regulatory expectations for quality, safety and efficacy. Our commitment is to create an advanced Quality System applicable across the life cycle of each product through a continuous, in-depth and forward-looking monitoring of the pharmaceutical and medical devices regulatory environment.
Quality is fully integrated into our global business processes, it is seen as a joint responsibility of all personnel and it is achieved by combining the collective ambition and individual contribution at all levels of Cooper Pharmaceuticals.
The quality of our products is assured by the cumulative effect of the premises, equipment, materials, services and personnel involved directly and indirectly in the processes.
Our main target is to produce high quality products that meet our customer’s expectations. Therefore, we :
- Ensure patient safety through risk management, quality assurance of products and compliance with at least ISO 13485:2016, ISO 9001:2015, ISO 37001:2016, ISO 14001:2015, GMP and Medical Device Regulation (MDR) 2017/745 (where applicable)
- Comply with all relevant applicable legal and regulatory requirements
- Seek for the continuously enhancement of customers’ satisfaction
- Track and apply new innovative technologies.
- Maintain and continuously improve the effectiveness of our Quality Management System in every aspect of business processes
- Invest in the continuous improvement of our personnel through continuous training.
Cooper has implemented a Quality Management System to serve the above objectives and is engaged to provide the necessary resources to support it.
For Cooper Pharmaceuticals,
NIKOLAOS MELAS
CEO
COOPER SA follows written procedures drawn up in accordance with international standards and GMP guidelines, as well as the ISO 9001:2015, ISO 13485:2016 standard and supervises all production processes as well as the reliability of installations, equipment, systems and all testing and production proceedures.
It also applies the principles and guidelines governing correct practice for storage and distribution of Medical Products and Devices, in accordance with Ministerial Decision DY8/1348/2004, and holds the relevant certificate from the competent certification agency, the Research Center for Biomaterials (EKΑPTY SA).
COOPER SA collects and monitors the safety data for all medicinal products marketed, in accordance with the guidelines governing Pharmacovigilance internationally.
For any report of an adverse event/reaction or a quality complaint about a COOPER SA product you can call at +30 2103462108 or send an email to the following address:
pharmacovigilance@koper.gr
For the needs of pharmacovigilance, the company collects personal data, based on the current legislation related to the safety of medicines. Data is stored for a period defined in the current legislation. Sending information or personal data to the above-mentioned email address, indicates your consent about data processing.
For FRESENIUS KABI products you can call at +30 210 6542 909 or send an email to the following address: FKHinfo@fresenius-kabi.com
Our objective in Cooper Pharmaceuticals is to ensure that every product, meets customers and regulatory expectations for quality, safety and efficacy. Our commitment is to create an advanced Quality System applicable across the life cycle of each product through a continuous, in-depth and forward-looking monitoring of the pharmaceutical and medical devices regulatory environment.
Quality is fully integrated into our global business processes, it is seen as a joint responsibility of all personnel and it is achieved by combining the collective ambition and individual contribution at all levels of Cooper Pharmaceuticals.
The quality of our products is assured by the cumulative effect of the premises, equipment, materials, services and personnel involved directly and indirectly in the processes.
Our main target is to produce high quality products that meet our customer’s expectations. Therefore, we :
- Ensure patient safety through risk management, quality assurance of products and compliance with at least ISO 13485:2016, ISO 9001:2015, ISO 37001:2016, ISO 14001:2015, GMP and Medical Device Regulation (MDR) 2017/745 (where applicable)
- Comply with all relevant applicable legal and regulatory requirements
- Seek for the continuously enhancement of customers’ satisfaction
- Track and apply new innovative technologies.
- Maintain and continuously improve the effectiveness of our Quality Management System in every aspect of business processes
- Invest in the continuous improvement of our personnel through continuous training.
Cooper has implemented a Quality Management System to serve the above objectives and is engaged to provide the necessary resources to support it.
For Cooper Pharmaceuticals,
NIKOLAOS MELAS
CEO
