Experience

Risk Management Plans
XEVMPD
Pharmacovigilance System Master File
Safety Variations
Drug Saftey Database management
Case Processing

Welcome to Pharamfile PV Services

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.

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. It is a key public health function.

We aim to provide a comprehensive ‘tailored to suit your individual companies’ needs’ Vigilance Service, including a Qualified Person for Pharmacovigilance (QPPV). Our team is able to undertake your whole (pharmaco) vigilance requirements or alternatively perform any specific task where your company may have a temporary lack of resource due to increased workload or vacancies.

Services

Pharmacovigilance

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. It is a key public health function.

Cosmetics

From July 2013 the current European Cosmetics Directive was replaced by the Regulation (EC) No. 1223/2009. This new regulation places an obligation on distributors to notify serious undesirable effects occurring in Europe to the local competent authority.

Medical Device

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.

Pharmacovigilance

We can assist to endeavour that your pharmacovigilance (PV) systems are properly established and that you ‘the Marketing Authorisation Holder’ meets your obligations to monitor the safety of marketed products in this rapidly-evolutionary environment.

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Pharmafile PV Services Limited a pharmacovigilance consultant to the pharmaceutical, veterinary, medical device and healthcare & cosmetic industries.

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