Our auditor's experience amounts to 140 pharmacovigilance audits, ranging from system and process audits to audits of database validation in the area of pharmacovigilance.
Conduct pharmacovigilance system and process audits
We have experience of more than 130 audits, ranging from system audits to more complex, e.g. database validation, signal management, EudraVigilance and XEVMPD submission audits.
Build and implement your quality system for pharmacovigilance
Achieve compliance with regulatory requirements in the EEA with the guidance from our experienced team.
Write your pharmacovigilance SOPs
Our team can write your documents from scratch or assist you in revising and updating them, assisting with gap analysis etc.
Review and improve your existing quality system and SOPs
We are experienced writers of quality documents, SOPs, working instructions, user manuals, but also more complex documents such as a company pharmacovigilance policy and a quality manual. Our flexibility and experience with different size companies allows us to provide you with solutions that are adapted to your organisation's specifics.
Prepare for pharmacovigilance inspections
Having participated in various EU pharmacovigilance inspections, we can assist you with the inspection preparation, logistics, communication tools and interaction with the inspection team.
Succeed mock pharmacovigilance inspections to current EU standards
If time allows, a mock pharmacovigilance inspection can serve as an excellent inspection preparation exercise. Our team will gladly carry out these mock inspections for your organisation.
Build and implement a Quality Assurance program for pharmacovigilance
Our experienced auditors can help training your Quality Assurance auditors during on site audits or via in-house training sessions.