New Guidance: ANDA Pre-Submission Facility Correspondence
The Food and Drug Administration (FDA) is issuing this revised dra...
BioPharma – Asia/Europe/USA Regulatory Updates, Jan 2023
USA | Europe (EU) | Asia
Europe (EU) MHRA updates biosimilar guida...
BioPharma – USA/Europe Regulatory Updates, Week 2 Nov 2022
Europe (EU) | USA | Asia
Europe (EU) EMA consults on planned updat...
BioPharma – USA/Europe/Asia Regulatory Updates, Week 1 Nov 2022
Europe (EU) | USA | Asia
Europe (EU) MHRA updates biosimilar guida...
Leveraging Automation in Pharma Regulatory
Regulatory affairs is playing a pivotal role in bringing products ...
Regulatory CMC Changes for Pharmaceutical Products
All the biopharmaceutical companies must follow respective nation’...
