Enzymatica wants to be a good stakeholder in the community and take responsibility for sustainable social development. As a medical device company, Enzymatica focuses on human health and well-being, and wants to use resources, regardless of whether they are raw materials, energy or human, as wisely and sustainably as possible. Regarding basic research, production and sales of products, the Company cooperates to a large extent with partners, many of whom actively work with sustainability issues.
In 2018 the company worked to ensure that Enzymatica complies with the requirements of the EU data protection ordinance (GDPR), along with strengthening its quality management system and production, which resulted in new certifications.
Quality and safety
Enzymatica develops medical devices in an environment that is regulated by laws, directives and standards. The Company’s procedures and documentation are formulated in accordance with the respective regulatory requirements. Documentation requirements are applicable for the entire life cycle of the product to guarantee that the product lives up to its performance claims. In summary, we take responsibility for ensuring that our products are safe, maintain a high standard of quality and live up to their claimed performance. In 2018 Enzymatica’s quality management system was certified to EN ISO 13485:2016. The Company’s new enzyme production facility in Iceland was also certified to ISO 9001 standards at the end of the year. The facility already worked in accordance with (though not certified to) Good Manufacturing Practices (GMP). During the first half of 2018 Enzymatica completed an initiative aimed at ensuring that the Company lives up to the requirements of the EU’s data protection regulation (GDPR). This effort involved taking inventory, analyzing and implementing measures to comply with the new rules.
Enzymatica does not engage in any environmentally hazardous activities that are subject to reporting or permits, but imports of the enzyme used in ColdZyme are reported to the Swedish National Chemicals Inspectorate product database, in which the operation is also registered. This enzyme is extracted as a by-product of fish processing and does not contribute to depletion of cod stocks. The wrapping and other packaging materials used for the products are recyclable. The contract manufacturer in Spain and most of the Company’s sales channels (pharmacies and health stores) are certified to the environmental standard ISO 14001.