In the current scenario of international health crisis, Diagnostic kits are considered as a few of the critical products to protect oneself and the society overall. Given the importance of diagnostic kits (extraction, screening, confirmation) in fighting back COVID-19, there is a growing demand for such products among the health care professionals and the other segments of global population. To live up to the increasing demand, the need of the hour is to quickly develop and market diagnostic kits and build the global supply chains stronger than ever.
However, the key factor en-route is the products’ adherence to regional compliance standards. it’s important to do a prior compliance check to fast track the extraction/screening/confirmation diagnostic kit’s global registration. As each country has its own Regulatory prerequisites for diagnostic kit’s classification, notification, licensing, and registration, at times, manufacturer’s compliance preparedness stands significant for quick health authority reviews and approvals. What if manufacturers are unsure of their targeted market’s regional Regulatory standards or procedures for the diagnostic kit registration?
As a proven Regulatory partner for many global companies, and with a vast global presence and robust affiliate network, Freyr shoulders the responsibility of registering diagnostic kits globally in adherence with the regional compliance standards.