COMPLIANCE
QUALITY ASSURANCE
COMPLIANCE: Top Priority & Core Value at Swixx Biopharma Swixx’ entire leadership team is devoted to maintaining the highest ethical and professional standards at our company. This is the top priority of all employees and is deep in our company culture. The company has already passed several MNC QA/GDP, Regulatory, PV, Medical and Compliance audits. We understand that the very success of our company depends upon a vigilant respect for, and flawless execution of, our partners’ compliance standards. We adjust and adapt our compliance system to our partners’ standards. Our default is always to the higher and more difficult standard Swixx BioPharma Code of Business Conduct Statement Charter Ethics and Compliance Committee COMPLIANCE HOTLINE Employees and Partners may contact Business Ethics Hotline 24 hours a day, 7 days a week and collect calls (reverse charges) will be accepted. If you are aware of a situation that you believe may be unlawful or unethical, you can contact Swixx BioPharma’s Ethics Hotline: For Non EU Countries: +381 11 44 26 345 or in emergencies/ 24-7 at +381 63 347 394 For Slovenia and Croatia +386 1 235 5109 or in emergencies/ 24-7at +386 30 220 942 For the Baltic Countries +370 686 08276 or in emergencies/ 24-7: Estonia +372 640 1030 Latvia +371 6 770 8347 Lithuania +370 5 236 9140 Or via email to compliance@swixxbiopharma.com If you are not satisfied with the reply you have received or if you would like to get another opinion, you can contact Michael Seeley at michael.seeley@swixxbiopharma.com
QUALITY POLICY Swixx BioPharma Company is committed to distribute “world-class” medicines, dietary supplements and medical devices that contribute to the health and well being of global community. Medicines released by Swixx BioPharma meet the highest standards for quality, safety, efficiency. We are committed to successful collaboration with all our customers, partners and stakeholders to ensure their expectations and needs. We are committed to provide the training to all our employees in their relevant and required areas, to increase their efficiency and competency, to meet or exceed the requirements and expectations of our customers and partners. Health and safety and environment protection are integral part of our quality strategy. We are committed to comply with the requirements of ISO 9001:2008, GxP, compliance regulations, codes standards and legal requirements. Swixx BioPharma Company will continuously improve its processes and always deliver products and services of reliable quality, with an aim to be one of the leading pharmaceutical companies in countries in which Swixx BioPharma operates. CERTIFICATES Quality is one of central company’s aims, alongside with safety, environmental protection and profitability. Swixx BioPharma Company has established documented Quality Management System, which includes requirements of EU GDP, EU GMP, ISO 9001. All Swixx BioPharma’s employees are committed to implement the quality management system in accordance with the relevant standards and our continuous business aim is improvement of its efficacy. Competent local and international institutions regularly conduct audits in Swixx BioPharma Company, while compliance with regulations has been verified by the issue of ISO 9001 certificates: ISO 9001 2015 certificate, Serbian office HACCP Certificate, Serbian office ISO 9001 2015 certificate, Slovenian office
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