PHARMACOVIGILANCE

Pharmacovigilance Services

Ongoing monitoring of product and patient safety is of paramount importance from the earliest stages of pharmaceutical development and throughout the product life cycle. Our team of expert PV consultants will guide you through the entire process, from pro-active risk consideration to post marketing PV systems in order to ensure that absolutely nothing is missed. 

We guarantee your product will meet you any national or international regulatory guidelines when ScientiaBio PV consulting oversee your PV policies and procedure. 

We provide solution to the requirements of our client’s organization and product. 

Our pharmacovigilance services:

  1. Pharmacovigilance Consulting- developing cost efficient short term and long-term strategies for ensuring pharmacovigilance compliance in different geographies
  2. Audit & Inspection readiness- to prepare in house PV teams, cross functional depts (regulatory, commercial & QA) & vendors by conducting mock inspections, review of documents, preparation of missing documents and helping teams to prepare for interviews
  3. Audit & Inspection Remediation: helping companies by preparing the responses to inspection findings and suggesting appropriate CAPA
  4. Preparation and training on SOPs
  5. Preparation & maintenance of PSMF, assessment of systems as per KPIs & documentation
  6. End to End PV operations including 
  • Processing of ICSRs, medical review and regulatory reporting, Preparation of PSURs/ PBRERs 
  • Preparation of RMPs & risk minimization measures 
  • Literature monitoring 
  • Monitoring of label/ package insert updates globally 
  • Signal detection 
  • Preparation of SDEAs and PV agreements

Pharmacovigilance Consulting

Audit & Inspection Remediation

End-to-End PV Operations

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