Freyr, a leading global Regulatory solutions and services provider supported a top American Multinational Pharmaceutical company for a US FDA Emergency Use Authorization (EUA) for a COVID-19 antiviral oral pill. From a larger perspective, the approval has indeed served Freyrâ€™s purpose of â€˜Together in Saving Lives,â€™ as the generic version of the
As stated by the FDA, the oral pill is available by prescription only and should be initiated as soon as possible after the diagnosis of COVID-19 and within five days of symptom onset. It is authorized for emergency use to treat adults with mild-to-moderate COVID-19 who are at risk of advancing to severe COVID-19 and/or hospitalization. Standing by the need of the hour and customerâ€™s requirements, Freyr supported the entire application and submission process within the time-critical deadlines. The most fulfilling aspect of the project is that the generic version of the same pill is set to release in markets like India soon to brace up the sub-continent against a high risk of COVID-19 progression.With the continuous outbreak of numerous variants of COVID-19, getting an opportunity to assist this noble cause itself is a great deal to serve the mankind we believe,â€ said Suren Dheenadayalan, CEO, Freyr Solutions. â€œFirstly, we would like to appreciate our customer for innovating this and thank them for their trust in us throughout the EUA application process. We are happy that the oral pill was authorized within a quick turnaround time and feel great to be a part of such project, which largely advocates the safety of humankind and aligns with Freyrâ€™s innate response to COVID-19,â€ added Suren.
Freyr is a leading, niche, full-service global Regulatory Solutions and Services Company supporting, Large, Medium and Small Size Global Life sciences companies (Pharmaceutical | Generics | Medical Device | Biotechnology | Biosimilar | Consumer Healthcare | Cosmetics) in their entire Regulatory value-chain, ranging from Regulatory Strategy, Intelligence, Dossiers, Submissions, etc. to Post- Approval/Legacy Product Maintenance, Labeling, Artwork Change Management, and other related functions.