Search


Swissmedic Guidnce: A Closer Look at Marketing Authorisation Transfers, DHPC, and RMP Submissions
As the Swiss life sciences sector grows increasingly global and collaborative, Switzerland’s regulatory authority, Swissmedic , continues...

Sharan Murugan
Jul 92 min read
Â
Â


India CDSCO Guidance: Pharmacovigilance Document for Marketing Authorization Holders of Pharmaceutical Products
India's CDSCO Pharmacovigilance released an updated guidance " Pharmacovigilance Guidance Document for Marketing Authorization Holders of...

Sharan Murugan
Sep 25, 20242 min read
Â
Â


MHRA Guidance: MAH Submission of Nitrosamine Risk Evaluation, Risk Assessment and Confirmatory Testing
Nitrosamines have become a significant concern in the pharmaceutical industry due to their potential carcinogenicity. In response to this...

Sharan Murugan
Jan 18, 20242 min read
Â
Â