Atlas Biologicals upholds the highest standards of quality for its serum products.
The International Serum Industry Association is focused on ethics, safety and education within the serum industry. The voting board of directors is composed of a consortium of representatives from industry leaders. These representatives from serum companies work together to standardize technical, testing, and import/export concerns. ISIA believes serum traceability is essential for good manufacturing practices.
TRAde Control and Expert System is the European system to manage importation of animals, semen and embryo, food, feed and plants. The purpose of this system is for three main points; traceability, exchange of information, and risk management. Traceability within the European Union is important for identifying the source of a problem to prevent any reoccurrences. This is important for transparency of our business across country lines. We want to facilitate the free exchange of information with all of our customers around Europe. When we allow open communication it creates a great environment for identifying potential risks. With these main goals in mind it harmonizes with the health certificates and trade documents mandated by local laws to make an effective system.
European Directorate for the Quality of Medicines and healthcare is a leading organization that protects public health by supporting and monitoring the quality standards for safe medicines. Atlas Biologicals, Inc. submits to the Council of Europe an application for certification of suitability.
Food and Drug Administration is a US government agency within the Department of Health and Human Services. Atlas Biologicals, Inc. submits an establishment registration (Title 21 CFR Part 807) every year. These documents discuss specific products or issues that relate to the design, production, labeling, promotion, manufacturing, and testing of regulated products. Guidance documents may also relate to the processing, content, and evaluation or approval of submissions as well as to inspection and enforcement policies.
U.S. Department of Agriculture- Animal and Plant Health Inspection Service created the International Animal Product Export Regulations (IREGS) to provide exporters requirements for importing animal-origin products. The primary role of APHIS is to provide certification about animal health status.