Implementing a system relating to authority guidelines

Pharmacovigilance is a complex process for which robust systems are essential. A strong PV system is an important part of the overall regulatory system. It reflects on the stringency and competence of the regulatory bodies in regulating the market and ensuring the safety and effectiveness of the pharmaceutical products and devices.

Health and safety is our watchword. Our service of pharmacovigilance is top notch as we help clients around the world through improved clinical development.

Fully equipped, our goal is to see your business grow and expand as we guide you through every step of the PV process to meet your every need. PRA is global and our team is fully prepared to handle large case volumes. We are also dedicated to supporting our clients all through the product’s lifecycle. You can access our services on a standalone basis or in an integrated form through Medical Information and Regulatory Services.

Clinical Pharmacovigilance

We employ a robust professional staff of healthcare providers that work across a broad range of therapeutic areas. Our PV experts ensure safety and consistency throughout your clinical trials.

  • Safety Management Plan (SMP) Development
  • Clinical Pharmacovigilance (PV) Auditing Services
  • Individual Case Safety Reports (ICSR) Processing and Submission
  • Aggregate Safety Report Generation and Reporting
  • Data Safety Monitoring Board
  • Medical Monitoring

Postmarketing Pharmacovigilance

We are proud to be an industry leader in providing global, comprehensive drug safety services to supplement or fully outsource your existing PV function.

We also help you with the following in Regulatory Affairs areas:

  • Initiate Pharmacovigilance department
  • Help you in preparing SOP with reference to MAH SOP in the country of origin
  • Advise and allocate a PV officer to you.
  • Act as Local Safety Officer (LSO)

For pharmaceutical products, we help you with:

  • Preparation of the PV system master file (PSMF) & SOPs
  • Preparation of all related PV reports.
  • Literature screening, ICSR collection and reporting.
  • PV Database
  • PV training
  • PV inspection readiness
  • Preparation and implementation of routine and additional risk minimization measures (SmPC, PIL, DCHP letter, Educational materials etc)

For medical devices, we help you with:

  • Preparation of Medical Device Vigilance System
  • Collection and submission of the incident and User Error Report
  • Pre-marketing assessment and Summary of Marketing History (SMH)
  • Applying Field Safety Corrective Actions (FSCAs)
  • Distribution of Field Safety Notices (FSNs)
  • Literature screening
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