HIGHLIGHTS
On-site Physical Audit to Remote Audit
A Risk-based Approach for Transition
It’s a known fact that drug manufacturers will have to relentlessly work on vaccine development and emergency products’ manufacturing to control the health crisis like COVID-19. In such scenarios, what if the manufacturers or regulators have no option for on-site audits? What options do they have to perform audit of vendors located in different geographies across the globe? The only option is to move from a traditional audit to remote audit or virtual audit. Unquestionably, remote/virtual audits are the future for conducting audits of low-risk processes that consist of documents, forms and records that can be reviewed from a desktop.
Freyr Supported FDA EUA for a COVID-19 Oral Pill
New Jersey, January 11, 2022: 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 Freyr’s purpose of ‘Together in Saving Lives,’ as the generic version of the pill is soon to hit a few other global markets.
Responsibly Responding To COVID-19
The unprecedented times of COVID-19 outbreak, has made the entire world standstill. It has challenged every aspect of life but not the spirit of humankind to fight back. Governments have quickly made significant measures to respond and businesses are rapidly changing their ways of functioning; so is Freyr.
