At Quality and Vigilance, we specialise in delivering expert pharmacovigilance consulting services and bespoke pharmacovigilance audit services tailored to the unique needs of your organisation. Our client-centric approach considers your specific business requirements, associated risks, regulatory complexities, and patient safety obligations, giving you a PV partner that understands your challenges from the ground up. From outsourced pharmacovigilance services that take the operational burden off your team, to dedicated EU QPPV services that keep you compliant with EMA and MHRA expectations, Quality and Vigilance is built to support pharmaceutical and life sciences organisations at every stage of their compliance journey.
Pharmacovigilance (PV) is the science and set of activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other medicine-related problems. For pharmaceutical companies, biotech firms, and medical device manufacturers, a robust PV system is not optional. It is a regulatory requirement enforced by the EMA, MHRA, FDA, and health authorities worldwide.
Pharmacovigilance is no longer a back-office compliance function. Regulators across the EU, UK, and US are increasing inspection frequency, tightening ICSR timelines, and scrutinising PV systems more closely than ever before. Organisations that treat PV as an afterthought face serious consequences including warning letters, licence suspensions, and reputational damage. Quality and Vigilance exists to make sure that never happens to your organisation.
We support MAHs with end-to-end pharmacovigilance outsourcing services, covering post-approval safety obligations, periodic safety update reports (PSURs), and global regulatory submissions to keep your licence secure.
Our pharmacovigilance consulting services help CROs deliver GCP-compliant safety monitoring, expedited adverse event reporting, and clinical trial PV oversight - strengthening the quality of every development programme.
We help pharmaceutical manufacturers achieve and maintain GxP compliance, audit-ready pharmacovigilance systems, and inspection preparedness - reducing regulatory risk across domestic and international markets.
From MDR and IVDR compliance to post-market clinical follow-up and vigilance reporting, our outsourced pharmacovigilance solutions help medical device companies manage safety obligations and protect market access.
We partner with biotech startups to build scalable, inspection-ready PV systems from the ground up covering QPPV services, safety database setup, risk management plans, and pre-launch regulatory strategy.
Our outsourced pharmacovigilance services enable generic drug companies to scale PV operations efficiently, manage signal detection, literature screening, and multi-territory aggregate reporting without expanding headcount.
When a regulatory inspection lands, you need specialists who have been in that room before. Quality and Vigilance brings focused PV expertise, proven audit methodology, and experienced EU QPPVs to every engagement, so your team walks into every inspection, submission, and authority query with complete confidence.
Pharmacovigilance is not a service we offer. It is the only service we offer. Every consultant, every process, and every tool at Quality and Vigilance is dedicated exclusively to pharmacovigilance, giving you a depth of expertise that no generalist consultancy can replicate.
EU QPPV professionals who know exactly what regulators expect. Our EU QPPV team brings hands-on regulatory experience across EMA and MHRA frameworks, acting as your single point of contact with health authorities and keeping your organisation continuously compliant.
A risk-based audit methodology that finds your gaps before inspectors do. Our pharmacovigilance audit services identify systemic weaknesses, prioritise findings by regulatory impact, and deliver clear CAPA recommendations your team can act on immediately.
Your complete PV function managed, delivered, and accountable in one place. From case processing and signal management to aggregate reporting and PSMF maintenance, our outsourced pharmacovigilance services give you a complete PV department without the overhead of building one in-house.
We have supported inspections before and we will get you through yours. Our consultants have worked alongside organisations through MHRA, EMA, and national competent authority inspections, preparing teams, documentation, and responses so nothing catches you off guard on inspection day.
Engagements shaped around your budget, your timeline, and your needs. Whether you need a one-time gap assessment, an ongoing QPPV retainer, or full end-to-end outsourced PV support, we structure every engagement to fit your organisation without ever compromising on quality.
Pharmacovigilance consulting services cover the full spectrum of support an organisation needs to build, maintain, and improve its PV system. This includes gap assessments, SOP development, PSMF authoring, signal detection process design, aggregate report preparation, and regulatory submission support. At Quality and Vigilance, our pharmacovigilance consulting services are tailored to your organisation's size, regulatory exposure, and specific compliance obligations.
Pharmacovigilance audit services assess whether your PV system operates in full compliance with applicable regulatory requirements including GVP guidelines, MHRA expectations, and FDA obligations. A typical audit covers SOP review, adverse event case processing workflows, signal detection processes, vendor oversight arrangements, aggregate reporting timelines, and PSMF accuracy. Every audit concludes with a risk-rated findings report and prioritised CAPA recommendations.
Outsourced pharmacovigilance services allow an organisation to delegate its entire PV function, or specific elements of it, to an external specialist provider. This typically covers case processing, signal management, aggregate reporting, PSMF maintenance, and EU QPPV provision. Companies most suited to outsourced pharmacovigilance services include smaller MAHs, biotech startups approaching product launch, and generic drug companies that need a fully operational PV function without the cost of building one in-house.
QPPV services provide organisations with a qualified, experienced Qualified Person for Pharmacovigilance who fulfils the mandatory regulatory role required by EMA legislation. Any company holding a marketing authorisation in the European Union is legally required to appoint an EU QPPV who is resident and operating within the EU. The EU QPPV oversees the entire pharmacovigilance system, acts as the single point of contact with health authorities, and carries personal accountability for PV compliance.
GVP guidelines recommend that pharmacovigilance systems undergo routine auditing at planned intervals based on organisational risk. For most Marketing Authorisation Holders, independent pharmacovigilance audit services every two to three years represent the minimum expected standard. Companies that have previously received regulatory findings, undergone significant system changes, or operate high-risk products should consider more frequent audit cycles to maintain continuous compliance.
Yes. At Quality and Vigilance, our outsourced pharmacovigilance services are structured to include EU QPPV provision as part of a fully managed PV function. This means your organisation benefits from a single, accountable partner handling case processing, aggregate reporting, signal management, PSMF maintenance, and EU QPPV oversight under one service agreement. This model is particularly effective for organisations operating across multiple EU markets who need consistent, regulation-aligned PV governance.
Pharmacovigilance consulting services typically involve expert advisory support for specific projects or challenges, such as a gap assessment, an audit programme, inspection readiness preparation, or PSMF development. Outsourced pharmacovigilance services go further by transferring the operational delivery of your PV function to an external provider on an ongoing basis. Many organisations begin with pharmacovigilance consulting services to assess their current system and then transition to outsourced pharmacovigilance services for long-term operational support.
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