AegirBio UK facility ISO 13485 compliant
We are pleased to announce that our product development site in the UK has been successfully, independently assessed and found to be compliant with ISO 13485:2016.
The ISO 13485 certification is an endorsement of the Quality Management System (QMS) that underpins the Company's position as a trusted manufacturer of medical devices. The accreditation is recognised on an international scale and is a critical part of gaining regulatory approval for our products. Moreover this development is important in enabling the Company to operate with greater capacity and improved efficiency and is a crucial step towards the development, manufacturing and distribution of our current products but also the ones included in our product pipeline portfolio.
AegirBio are committed to the continuous improvement of its functions and the services it provides, always keeping our customers’ needs at the forefront of the decisions we make. This ISO certification is evidence of our commitment to the highest standards of product performance, quality, consistency, and reliability.
For more information, please contact:
ir@aegirbio.com
About Aegirbio
Aegirbio is a Swedish diagnostics company offering tests to monitor and optimize the dosing of biological drugs by means of a unique, patented technology platform. Biological therapies is the fastest growing segment of the pharmaceutical industry; a quarter of all drugs are projected to be biological in 2020. At the same time, drug concentrations vary tremendously (up to 100 times) in patients that receive biological drugs in standard doses.
The result of this one size fits all-approach is that patients with low drug concentrations do not respond to treatment, while excessive drug concentrations increase the risk of adverse effects in others. The uncertainty surrounding dosing results in overdosing or underdosing in about 55 percent of the cases, which causes unnecessary costs and suboptimal clinical outcomes.
The Company's tests for optimal dosing of biological drugs will be focused on neurological disorders, autoimmune diseases and cancer. In the first quarter of 2020, Aegirbio initiated sales in the U.S. of the MoNATor test for the drug Tysabri, which is used for treatment of the neurological disorder Multiple Sclerosis (MS). Aegirbio’s goal is to launch a total of four tests before 2023. Diagnostics will be offered through laboratory testing as well as in the form of a P.O.C. (Point of Care) test for use in hospitals and health centres. The plan further includes P.O.N. (Point of Need) tests for use at home.
For more information, please visit Aegirbio’s website, www.aegirbio.com
Certified adviser for the company is Eminova Fondkommission AB | +468-684 211 00 | info@eminova.se