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Sep 252 min read

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...

Jan 182 min read

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...