We offer a full suite of vigilance and regulatory compliance services, centred on pharmacovigilance and extending across related domains. All service pages are accessible from our site navigation:
Who We Work With
Our Services
Our client base spans the gamut of the life sciences industry. Pharmafile PV Services Limited is a pharmacovigilance consultancy to the pharmaceutical, veterinary, medical device and healthcare & cosmetic industries.
We support
- Small and Virtual Biotechs & Pharma Start-ups: who often need an outsourced pharmacovigilance department to set up their safety systems from scratch or prepare for first approvals.
- Mid-sized and Large Pharmaceutical Companies: that may have established teams but require external expert support for special projects, QPPV cover, or overflow case processing and reporting.
- Medical Device and Diagnostics Companies: in need of building or strengthening their post-market surveillance and vigilance processes.
- Consumer Health, Cosmetics, and Supplement Brands: seeking to comply with cosmetovigilance and nutrivigilance expectations, ensuring any safety issue is managed and reported properly.
- Veterinary Health Companies: looking for pharmacovigilance know-how that covers the nuances of veterinary products.
- Ensuring Safety Beyond Compliance Pharmacovigilance & Vigilance Services
- Pharmacovigilance at the Core
- Why Pharmafile
Pharmafile PV Services Limited is a specialist consultancy providing end-to-end pharmacovigilance and post-market regulatory vigilance for medicines, medical devices, cosmetics, and related health products across Europe and the United Kingdom. Pharmacovigilance is the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem. The principal purpose of a vigilance system is to improve the protection of health and safety of patients, users and others by reducing the likelihood of reoccurrence of incidents related to the use of medical or other healthcare products. We provide a comprehensive, tailored vigilance service including a Qualified Person for Pharmacovigilance (QPPV) with the ability to undertake your whole pharmacovigilance requirements or alternatively perform any specific task where your company may have a temporary lack of resource due to increased workload or vacancies. Pharmafile PV Services Limited is a pharmacovigilance consultant to the pharmaceutical, veterinary, medical device and healthcare & cosmetic industries.
Pharmacovigilance the process and science of monitoring the safety of medicines and taking action to reduce the risks and increase the benefits of medicines is a key public health function and the foundation of all our services. We establish and manage comprehensive pharmacovigilance systems for human and veterinary medicinal products, ensuring that you as the Marketing Authorisation Holder meet all obligations to monitor the safety of marketed products in a rapidly evolving regulatory environment. Our established areas of experience include Risk Management Plans, XEVMPD, Pharmacovigilance System Master File (PSMF) development and maintenance, Safety Variations, Drug Safety Database management, and Case Processing. Our senior experts can act as your outsourced Qualified Person for Pharmacovigilance (QPPV), providing the single point of contact with regulators for safety matters and oversight of your pharmacovigilance system.
- related vigilance disciplines. Our specialties span QPPV Services, Pharmacovigilance Outsourcing, Pharmacovigilance Consulting Services, and Cosmetics. You benefit from seasoned judgement and a best-practice approach shaped by extensive regulatory experience.
- Independence and Objectivity: As a privately held company, we provide an independent, objective layer of oversight. We identify compliance gaps or safety concerns without bias and help you address them effectively.
- Comprehensive Multi-Domain Coverage: We understand that safety is not siloed. Our service range covers Cosmetovigilance, Herbal Vigilance, Medical Device Vigilance, Medical Information, Nutraceuticals, QPPV Services, Pharmacovigilance, and Veterinary Pharmacovigilance. This breadth means you do not need to juggle multiple vendors for different product categories.
- Flexible, Client-Centric Delivery: We pride ourselves on working in a client-focused, adaptive manner. Whether you need full-scale outsourcing or occasional support, we tailor our services to fit. We are committed to a ‘Best Value Customer Focus’ delivering expertise, quality, flexibility and client satisfaction.
- Quality Without Compromise: We operate under stringent internal quality controls. Our standard operating procedures are comprehensive and kept up to date with regulatory changes. We regularly audit our own processes to ensure efficiency and compliance.
Pharmacovigilance & QPPV Services
We serve as your specialised pharmacovigilance department, or augment your existing team, to ensure medicines are continuously and correctly monitored. Pharmacovigilance is the process and science of monitoring the safety of medicines and taking action to reduce the risks and increase the benefits of medicines. We can assist to ensure that your pharmacovigilance systems are properly established and that you meet your obligations to monitor the safety of marketed products. Our team manages end-to-end drug safety: collecting and evaluating adverse drug reactions, preparing regulatory submissions, performing signal detection, and maintaining your PSMF. When needed, we provide an experienced EU/UK QPPV to oversee your safety obligations.
Cosmetovigilance & Consumer Product Vigilance
We operate a cosmetovigilance programme for companies in the cosmetics and personal care sector. From July 2013, the current European Cosmetics Directive was replaced by Regulation (EC) No 1223/2009, which places an obligation on distributors to notify serious undesirable effects occurring in Europe to the local competent authority. We support your Responsible Person in the EU/UK by collecting reports of adverse reactions to cosmetics, performing causality assessments, and completing statutory Serious Undesirable Effect (SUE) notifications within required timelines.
Medical Device Safety & Vigilance
We support manufacturers and distributors of medical devices in meeting post-market surveillance and vigilance requirements. The Medical Devices Directives provide that adverse incidents are evaluated and, where appropriate, information is disseminated in the form of a National Competent Authority Report (NCAR) with the objective of preventing repetition of such incidents through the adoption of appropriate field safety corrective actions. Our approach integrates device vigilance with your quality management system to ensure incident reporting, trend analysis, and risk-benefit monitoring for devices are handled in line with regulatory expectations.
Nutraceutical & Herbal Vigilance
We offer specialised vigilance for herbal medicinal products and nutraceuticals/food supplements. For herbal medicines, we manage safety monitoring and periodic safety reports as required under traditional use registration schemes. For nutraceuticals, we implement nutrivigilance practices collecting consumer adverse feedback, evaluating potential health risks, and advising on regulatory actions. Our cross-disciplinary insight ensures that herbal and nutritional products remain safe and any signal of concern is addressed promptly through the proper regulatory channels.
Medical Information & Safety Communications
Our Medical Information service complements vigilance by serving as a knowledgeable point of contact for inquiries about your products. Our medical information team is trained to recognise and capture any safety-related information from inquiries, working hand-in-hand with our vigilance team so that a question or complaint hinting at an adverse effect is seamlessly routed into the safety system. We also assist in preparing and disseminating safety communications if required to inform stakeholders of new safety findings or recall actions.
Quality & Compliance Support
Beyond vigilance, we help ensure your overall quality and compliance framework supports product safety. We advise on and audit quality systems with an eye to their interfaces with safety monitoring. Our team can prepare you for regulatory inspections by conducting pre-inspection audits and mock inspections focused on safety compliance.
How We Support Clients
We work as a flexible, reliable extension of your team. Our approach is collaborative and customised:
We adapt to your organisation’s structure and needs, whether you require full outsourcing of pharmacovigilance and vigilance functions or targeted support for specific tasks. Our team is able to undertake your whole pharmacovigilance requirements or alternatively perform any specific task where your company may have a temporary lack of resource due to increased workload or vacancies.
From the start of our engagement, we assign dedicated project leads to coordinate all activities and maintain clear communication. We use proven procedures and secure tools to manage data and deadlines, ensuring you stay in control and have full visibility into safety issues and actions.
Our model allows us to scale support up or down as your situation changes. If you have a new product launch or an unexpected regulatory request, we can quickly devote additional resources. This flexibility ensures cost-effectiveness and continuity you get the support you need, when you need it, without compromising on quality or compliance.
Getting Started
If you are looking to strengthen your product safety and regulatory compliance, we are ready to help. Contact our team for a confidential discussion about your needs whether it is establishing a new pharmacovigilance system, preparing for an inspection, or obtaining specialised vigilance support for a particular domain.
Pharmafile PV Services Limited a pharmacovigilance consultant to the pharmaceutical, veterinary, medical device and healthcare & cosmetic industries.
About UsOur Services