PrimeVigilance

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Guildford, UK
30th June 2010

PrimeVigilance Limited today announced that it has established offices in Krakow, Milan and Zagreb in line with its strategy of setting up a Europe­wide operating structure from its Guildford head office.

PrimeVigilance has responded to market demand by expanding its team of pharmacovigilance specialists and now has almost twenty active staff, as well as a global team of consultants, supporting pharmacovigilance and clinical safety assignments. This recruitment drive will continue into 2010 as PrimeVigilance builds up its operational base to meet increasing demand.

PrimeVigilance is pleased to have won several contracts from companies based in Europe, North America, and Asia / Pacific Rim during its first full year of trading. PrimeVigilance supports these existing clients by providing a global pharmacovigilance system that covers more than 80 countries.

There has been an increase in non­-European companies seeking assistance when entering the European market, but many companies (especially those that are new and emerging and even some established organisations) only realise the complexity of the European pharmacovigilance regulations at a late stage in the development of their strategy. During the last year, PrimeVigilance has put in place a complete pharmacovigilance system which fulfils the expectations laid down by the European regulators, and includes a team of EU Qualified Persons for Pharmacovigilance, a suite of pharmacovigilance controlled documentation and safety data exchange agreements, an ARISg safety database with custom­built tracking system, experienced personnel and full disaster recovery. PrimeVigilance is therefore well positioned to offer compliant pharmacovigilance support to any pharmaceutical or Biotech Company.

One of the founding directors of PrimeVigilance, Dr Elliot Brown said:

"PrimeVigilance is very pleased with the remarkable progress we have made in the past 18 months. The company is now eminently well positioned to provide cost­effective, full service pharmacovigilance solutions and welcomes enquiries from potential clients. We should be thought of as offering life insurance for pharma and biotech companies in these challenging times."

For more information contact:

Jonathan West
PrimeVigilance Ltd
Phone: +44 (0) 1483 688 349
Fax: +44 (0) 1483 688 348
info@primevigilance.com
www.primevigilance.com

About PrimeVigilance

PrimeVigilance has been set up as a joint venture between Dr. Elliot Brown and Dr. Miroslav Reljanovic, the founder of the Ergomed Group. These two experts have formed a UK­registered multinational company which provides an innovative, top quality and cost­effective safety operation for small­and medium­sized pharmaceutical and biotechnology companies. PrimeVigilance already has an established international footprint and a heritage of excellence and leadership. Dr. Elliot Brown's existing consultancy has an enviable reputation of a decade in PV, with a network of expert associates spanning three continents. These include former senior regulators and consultants with extensive industry experience. To complement this top­level, global consultancy support, the Ergomed Group brings an experienced operational dimension to the PrimeVigilance offering. With offices in the UK, Germany, Southern and Eastern Europe, Russia, the USA and the Middle­East, the Ergomed Group is a quality­focused organisation with outstanding staff and several years experience with the ARISg safety database and clinical safety management. PrimeVigilance will fill the gap between the large multinational CROs that do not provide a service geared towards post­marketing surveillance for small and medium sized companies, and the small service providers that do not have the critical mass, expertise or wide international presence needed to reassure that patients and products will be adequately protected.