RAPS – 2019 Regulatory Convergence Round-up by MakroCare
Recently concluded RAPS- 2019 regulatory convergence at Philadelph...
Deadline Extended for DMF Type III eCTD Submissions by FDA
This being the third time in a row, the United States Food and Dru...
Regulatory CMC Changes for Pharmaceutical Products
All the biopharmaceutical companies must follow respective nation’...
Post-Market Surveillance Planning and Challenges under EU MDR
PMS is a collection of processes and activities used to monitor th...
EUDAMED and EU Medical Device Nomenclature
The European Commission explain the details of how a future system...
Use of Retrospective RWD for EU MDR Compliance
As EU MDR has already entered into force and will be applicable in...
