Pharmacovigilance & Medical Information

pharmacovigilance and medical information

We offer Pharmacovigilance support to customers which can be tailored to meet Companies specific needs. This includes:

  • Setting up quality systems to fulfill Marketing Authorisation Holders Pharmacovigilance obligations
  • Weekly literature searching to identify potential adverse events related to Marketing Authorisation Holders products
  • Collation, assessment, follow-up and reporting of spontaneous adverse reactions received by the Marketing Authorisation Holder
  • Electronic reporting via EVWeb
  • Review of ASPRs
  • Preparation of Periodic Safety Update Reports
  • Safety reviews
  • SmPC safety variations
  • Appropriate Qualified Person and Deputy Qualified Person for Pharmacovigilance including 24-hour cover

In addition we offer the following:

  • Provision of Pharmacovigilance training
  • Auditing existing Pharmacovigilance systems
  • Preparation for and assistance during MHRA Pharmacovigilance inspections

Make An Enquiry:

For any further information please fill out the form below and we will get in touch as soon as possible: