Blogs
Pharma/Biotech – USA, Europe Re…
USA
No Big-Picture Impact for Manufacturers in CMS IRA Updates
In the face of multiple lawsuits…
Medical Devices-USA/Europe Regulatory…
USA (FDA)
Content of Premarket Submissions for Device Software Functions
The purposes of this d…
What Pharma Companies need to know ab…
EU MDR
The Medical Device Regulation (MDR), which was adopted in April 2017, changes the European…
ANVISA New Medical Device Regulation …
On March 1st, 2023, the new RDC (Resolution of the Collegiate Board) 751/2022 released by the Brazili…
Regulatory Database, a Boon to the Ma…
Many Organizations are relaying on the Regulatory Intelligence databases due to burden of collecting,…
Pharma/Biotech – Asia, ROW Regu…
ASIA
India
India starts mandatory tests of exported cough syrups after child deaths
India wi…
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