Idorsia is proud to be working in a highly regulated industry with codes of conduct, guidelines and regulations that are designed to protect patients, healthcare professionals and the reputation of the industry.
To ensure that our employees understand how important it is to work in a compliant, ethical and transparent manner, Idorsia has implemented a number of policies and guidelines covering the breadth of its business areas. Access to these documents is ensured for all employees via an electronic quality-management system.
Jean-Paul Clozel, CEO
"Ensuring quality across our business is critical to our survival and needs to be ingrained across all functions. We are working in a highly regulated industry, so complying with recognized standards and practices is a fundamental requirement to generating trusted data and gaining approval for our drugs. A reputation for quality in all we do, helps to build trustful relationships with all stakeholders, such as the regulatory authorities, prescribers and our patients."
Safety & quality of products
Patient safety, through the optimal performance and quality of products, is fundamental to our company’s mission. Idorsia takes seriously its commitment to ensure that our products have and maintain an acceptable risk-benefit profile when used in accordance with the product labeling and good medical practice. The company performs extensive and robust non-clinical and clinical testing to identify the safety and tolerability profile of products and, once approved for use, the products will continuously be monitored through the use of post‑marketing surveillance and spontaneous reports from prescribers and patients. It is the responsibility of all Idorsia employees to promptly report any adverse drug experiences that they become aware of that could be associated with an Idorsia product to the company’s Global Drug Safety Department.
Idorsia is also committed to quality in the manufacturing, packaging and testing of its products. To ensure patient safety, it strives to meet or exceed applicable regulatory authority requirements for current Good Manufacturing, Clinical and Laboratory Practices (cGXPs). Idorsia is required to compile and maintain numerous records and to file reports and applications with various government agencies. Idorsia requires that all employees who prepare information, records or submissions for governmental agencies, or who otherwise deal with such agencies, do so diligently, accurately, completely and with absolute integrity.