For all your Regulatory Affairs challenges

Pharmacovigilance

Cambridge Regulatory Services can provide you with a complete PV service at price to suit your budget 

 

Work with us for:

Competitive Pricing

  • Set up primarily for our generics clients, in response to requests for a service that covers all the legal requirements at an affordable price
  • We offer a value for money service and multiple product discount packages, which means that your own profit margins can remain competitive.

EU wide Service

  • With associates in every EU member state we can provide you with a truly pan European service.  If you want to use your distributors to carry out local activities we can train and audit them.  If you prefer we can take care of the whole process

Cover in the US and Asia

  • Through our Partners in the USA and India our service can be extended to these regions.

What is Pharmacovigilance?

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.

Is it mandatory?

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.

Is your company equipped for PV?

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:

  • Run your own system - incurring large set up costs and requiring the employment of a highly skilled team
  • Let Cambridge Regulatory Services handle your daily pharmacovigilance needs with our expert in-house team - at a very competitive rates

Benefits of CambReg’s PV Services

Our experience

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.

What we offer

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.

Services Menu

System Set up:

  • Provision of client–tailored SOPs
  • Provision of PSMF
  • Provision of a Risk Management Plan, if required for your product
  • Use our in-house system for processing and monitoring your pharmacovigilance data
  • EudraVigilance registration
  • Provision of a QPPV /Deputy QPPV
  • Provision of medical expert

Ongoing Activities:

Detection

  • Regular literature searches

  • Monitoring of Health Authority PV databases where appropriate

Collection/Evaluation/Review

  • Comprehensive Adverse Event management
  • Medical Safety Assessment of individual case reports
  • Electronic Reporting of Adverse Events to the EMA and National Health Authorities
  • Expedited reporting of Serious Adverse Reactions

Preparation and submission of PSURs

Our Team

  • QPPV and Deputy QPPV – in house
  • Where required Local Qualified Person in any EU member state
  • Medical Expect – in house
  • Pharmacovigilance Safety Officers throughout  the EU (CambReg’s PV Associates)

Quality Assurance

  • QC of all in-house PV activities
  • Audits performed on CambReg’s European PV Associates
  • Preparation for Health Authority inspections