Our specialist team looks at the big picture and provide a tailored service to match your needs.

We provide a range of in-house bespoke pharmacovigilance services which will add value to your project.

Whether you require a one off service or the complete package we offer flexible solutions to meet your needs. We offer a wealth of experience working with UK and international clients covering all phases of drug development from innovative and generic products to herbals and advanced therapies.

EEA Qualified Person and Quality

Assurance that your EEA QPPV requirements are in safe hands 24/7

The role of the EEA Qualified Person for Pharmacovigilance (EEA QPPV) is critical for a company and the choice, experience and knowledge of the EEA QPPV should not be overlooked in the safety management of your products; they are responsible for ensuring your systems and processes are in compliance with the legislation. The services are supported by a full back-up system to comply with the 24/7 requirement and GoldenZone’s internal Quality Management System (QMS).

  • Provision of an appropriately trained and qualified individual to cover your requirement for an EEA QPPV and deputy to QPPV. This includes the 24/7 availability and contact point for Regulatory Authorities for all safety concerns.
  • Assistance with the set-up of local QPPVs in the EEA countries with a local requirement.
  • Oversight of the global system of Pharmacovigilance for the Marketing Authorisation Holder (MAH).
    Quality Assurance Services
  • Review and manage compliance metrics (including ICSR and aggregate reporting).
  • Undertake “mock” PV audits for PV inspection readiness including gap analyses.
  • Assist in development and management of your QMS and compliant PV processes according to Good Pharmacovigilance Practises (GVP) including management of non-conformance and CAPAs.
    Contract and Agreements
  • Creation of client specific templates for Safety Data Exchange Agreements (SDEAs) including authoring or review of these agreements and support in routine reconciliation of safety information with client partners.

Post-Marketing Pharmacovigilance

We provide quality assured Pharmacovigilance (PV) Systems according to regulatory standards.

Based on global experience, our goal is to help our clients be compliant with the relevant PV legislation along with managing the risk-benefit profile of products. GoldenZone can support your PV requirements from your Marketing Authorisation Application (MAA) through the entire post-marketing life cycle. We have experience of national approval through decentralised procedures to centralised approval in the EU via the EMA.

  • Implementation of your PV system
  • ICSR (Individual Case Safety Reports) Case Management
  • Reconciliation and compliance including SDEAs (Safety Data Exchange Agreements)
  • E2B Compliant Safety Database
  • EudraVigilance Registration and Testing
  • Electronic Reporting & Product Reports (XEVMPD)
  • Aggregate Safety Reports: PBRERs & PSURs (Periodic Benefit Risk Evaluation Reports & Periodic Safety Update Reports)
  • Pharmacovigilance System Master Files (PSMFs)
  • Risk Management Plans (RMP’s) and Risk Minimisation
  • Signal Management and Ongoing Benefit Risk Evaluation
  • Literature Searches and Evaluation
  • Routine Signal Management
  • PV Audits and Inspections

Clinical Trial Safety Management

Our robust in-house pharmacovigilance system helps detect and manage safety issues early in the product lifecycle.

Safety monitoring in clinical trials is integral to the conduct of clinical research to ensure both patient safety and integrity of study data. We have an extensive understanding of regulatory reporting requirements and continuous regulatory intelligence ensuring ongoing compliance.

  • Responsible Person
  • Eudravigilance Electronic Reporting via EVWEB
  • Product Entry (XEVMPD)
  • E2B Compliant Safety Database
  • SAE (Serious Adverse Events) Case Management
  • SUSAR (Suspected Unexpected Serious Adverse Reactions) Expedited Reporting
  • Aggregate safety reporting (e.g. Preparation and submission of DSURs, Annual Safety reports)

We’re listening so let’s talk.

Whoever you deal with will treat your request as a priority with a smile on their face.

EMAIL US » +44 (0)33 33 44 55 45

How are we different?

We develop strong working partnerships with our clients. Find out about the team companies trust time and time again.