Meher Pharma International...

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PHARMACOVIGILANCE

Medicine is a double edged sword either saves life or kills life. It all depends how you care medicine from manufacturing till distribution points. How do you store and how clinicians give feedback on effects and side effects. How soon clinicians respond to the company regarding adverse effects of medicine and how vigilant a company in collecting and responding to the regulatory body and to the society.

In this scenario, an average drug costs over USD 1 billion to bring it to fruition from discovery through development and launch phases. These expensive “ blockbusters “face even riskier futures in the event of regulatory drug withdrawal decision/recalls that could bring companies to closure. Ironically, such recalls have been followed by punitive public payouts in billions of dollars, forcing the pharmaceutical industry to embrace a paradigm shift towards predictive and proactive pharmacovigilance. We advise for the following pharmacovigilance services

  •   Pharmacovigilance System Master File (PSMF)
  •   Risk Management Plan (RMP)
  •   Periodic Safety Update Report (PSUR)
  •   Adverse Drug Reaction Monitoring (ADRM)
  •   Customised Scientific Manuscript Writing
  •   Individual Case Safety Report Processing
Pharmacovigilance
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