
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
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Pre-marketing reports: DSUR
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Post-marketing reports: PSUR, PBRER (incl. response to PSUSA) and Addendum Clinical Overview
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Risk Management Plan

Medical Affairs
Product reviews
Harmonisation projects
Clinical Overviews
CCDS updates

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