Author: Vigilare Biopharma

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Biologics: Transforming Cancer Treatment for Improved Safety and Efficacy

Biologics: Transforming Cancer Treatment for Improved Safety and Efficacy

Biologics have transformed the landscape of cancer treatment, offering targeted and safer therapeutic options. These drugs are engineered to interfere with specific molecules or pathways involved in cancer growth, typically derived from living organisms or

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The Safety Specification ICH e2e Guidelines

Scope of The Safety Specification ICH E2E guideline in Pharmacovigilance practice

Pharmacovigilance is the science and practice of monitoring, evaluating, and managing the safety of medicinal products. It is essential to ensure that the benefits of a product outweigh its risks, and to identify and prevent

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Regulatory News

Pharma and Regulatory News Sep 22

New ZLG Document on Transport Verification Published At the end of August, the German Central Authority of the Länder for Health Protection with regard to Medicinal Products and Medical Devices (Zentralstelle der Länder für Gesundheitsschutz

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Case Study of a manufacturer focused on Branded Formulations, Specialty Generic Injectables, Synthetic Biology, Vaccines and Biologics

Case Study An India based manufacturer, focused on Branded Formulations, Specialty Generic Injectables, Synthetic Biology, Vaccines and Biologics At A Glance Challenges Medical Inquiries Product Complaints Adverse Drug Experience Reporting Other Categories Combination of the

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Adverse Drug Reactions Reported Each Year On Rise

ADRs refer to harmful or unintended reactions caused by the use of medications or medical treatments. They range from mild side effects to severe and life-threatening events

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