Pharmacovigilance
Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem. The Pharmaceutical Industry is required to implement Pharmacovigilance to ensure the safety of drugs in circulation. The implementation will improve the pharmaceutical industry's credibility and public's trust in the products.
Good pharmacovigilance practices (GVP) are a set of measures drawn up to facilitate the performance of pharmacovigilance.
Our tagline are regulatory and deadline compliance; efficient; ease.
Our services:
[*]Services of QPPV (Qualified Person for Pharmacovigilance) who have received pharmacovigilance training
[*]ICSR management
[*]Periodic Safety Update Reports (PSUR) / Periodic Benefit-Risk Evaluation Report (PBRER)
[*]Post-marketing study (study protocol and study design)
[*]Scientific literature searching and reporting
[*]Priority assessment of medicines that will be searched for literature reporting
[*]Monitoring and reporting of the action taken by MAH and regulatory authority of other countries
[*]Risk Management Plan (RMP)
[*]Documentation and Reconciliation
[*]Audit
[*]Training
Entrust your pharmacovigilance concerns in the experienced hands of our Team.
Ethics in pharmacovigilance: "To know of something that is harmful to another person, who does not know, and not telling, is unethical."
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