With global regulators adapting guidelines in response to the pandemic, Regulis has offered assistance with ventilator development and registration, and development and registration of other devices and medicines relevant to the fight against COVID-19.
Regulis has stepped up and offered its resource and expertise to help in the fight against COVID-19. We have an expert team of pharmaceutical regulatory consultants who are able to provide support in the regulatory affairs and quality assurance areas, with particular expertise in registration of and quality systems for medical devices, drug-device combination products, pharmaceuticals and biotechnology products.
With an increased demand for ventilators and other personal protective equipment (PPE), our medical device experts can ensure that manufacturers produce devices, such as breathing systems and test kits, which are safe and effective for patients, whilst meeting the necessary regulatory and quality requirements and standards.
Existing drug treatments may be effective in treating coronavirus patients. Our medicines regulatory team can assist with aspects of medicine re-purposing regulations, as well as rapid vaccine and medicine registration.
Regulis remains fully operational, although currently our experts are working remotely as per government instructions. However, members of our team can be available for urgent site visits if required, given the seriousness of the current pandemic.
We are keen to assist with the fight against coronavirus so for more information on the support Regulis can provide, please click here.
Please contact for assistance or just to arrange an initial conversation. We will respond immediately to any enquiries received.