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 2019 the Company was engaged in updating the quality system and the technical documentation of the products.
Enzymatica develops health care products in an environment, that is regulated by laws, directives and standards. The Company’s procedures and documentation are formulated in accordance with the requirements applicable for respective health care product. 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.
During the first half of 2019 improvements were made of one third of the Company’s processes to prepare for the recertification of the quality management system. The recertification of Enzymatica’s quality management system according to EN ISO 13485:2016 was conducted in a successful way and was approved in September 2019 without any major remarks. In order to prepare the quality management system for the new European medical regulation, which will come into effect in May, 2020 gathering of knowledge and competence improvement were performed during the year to meet the new requirements. During the latter part of 2019 a cosmetic product, based on the same enzyme technology as the medical device (ColdZyme®), was developed. The necessary technical documentation for the new cosmetic product was produced during the fall according to the requirements in the European cosmetic regulation. Enzymatica also commenced an effort to strengthen and update the technical documentation for ColdZyme.
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.