PharmaCentral

PharmaCentral offers a wide range of pharmacovigilance consultancy services with the necessary tools and expertise to assist you in monitoring the safety of your marketed medicinal products and meeting your regulatory reporting requirements. We partner with our clients from start to finish, focusing on their needs while developing effective strategies and producing high quality and timely deliverables and outputs. With a wealth of experience in pharmacovigilance and medical affairs gained through appointments in both pharma and CRO, we can create tailor-made service packages based on your pharmacovigilance requirements.

Aggregate Report Writing

  • Pre-marketing reports: DSUR

  • Post-marketing reports: PSUR, PBRER (incl. response to PSUSA) and Addendum Clinical Overview

  • Risk Management Plan

Medical Affairs

  • Product reviews

  • ​Harmonisation projects

  • Clinical Overviews

  • CCDS updates

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Consultancy Services

  • Audit preparation

  • CAPA report preparation

  • PV department set-up

  • Pharmacovigilance training

  • Ad-hoc consultancy requests

Other Services

  • Signal Management

  • Literature review + analysis

  • PSMF creation / maintenance

  • SOP/WIN/Template creation

 

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