Cambridge Regulatory Services can provide you with a complete PV service at price to suit your budget
EU wide Service
Cover in the US and Asia
To build and update the safety profile of a medicinal product to be kept up to date, it is necessary to collect and evaluate reports from healthcare providers, patients and the scientific literature on all adverse events that occur in connection with the use of the medicine.
As a result of the monitoring of adverse events, over the course of time, new information about the hazards associated with a particular medicine can come to light. Any changes to the safety profile need to be reflected in the Summary of Product Characteristics and Patient Information Leaflet, the updated information ultimately helps to prevent harm to patients.
According to European Directive 2001/83/EC and its subsequent amendments, the holders of marketing authorisations are required to have a functional pharmacovigilance system in place. This is to ensure that they can detect, receive and adequately respond to any information that is of safety relevance to the medicinal products they place on the market.
You must have a system in place by the time you make your first Marketing Authorisation Application for a medical product (including generics and herbal medicines). You have two main options:
CambReg has been runnnign a PV service since 2009 and we have in our PV team, individuals with more than 20 years experience in this field. We have our own in-house QP, Deputy QP, medic and safety manager.
With increasingly stringent regulatory requirements, expert knowledge and the assistance of a team you trust are essential.
By letting CambReg’s pharmacovigilance team keep watch over your products, you can rely on thorough scientific and medical evaluation, prompt and adequate responses to all reported adverse events, and on excellent communication with both you as the Marketing Authorisation Holder and with all other parties involved.
System Set up:
Preparation and submission of PSURs