Press Release London, UK/Prague, CZ – 29 November 2016

PrimeVigilance Press Release

PrimeVigilance and PharmInvent combine to create leading, international full service pharmacovigilance, medical information and regulatory service provider

London, UK/Prague, CZ – 29 November 2016: PrimeVigilance and PharmInvent are pleased to announce that they are now working together as an integrated service provider following the acquisition of PharmInvent by Ergomed plc, the owner of PrimeVigilance.

The companies will continue to trade under their current names and there will be no changes to any of the existing client arrangements, including staffing or any other business relationships.

There is however clear intention to share expertise and ensure that existing clients continue to receive the highest standards of service and also to introduce new services or expertise where appropriate and also to attract new clients from across the globe. The combination of PharmInvent and PrimeVigilance creates one of the world’s largest specialist drug safety service providers with over 300 highly qualified staff based in UK, Europe and USA. The combined range of service offerings is excellent with both companies benefiting from the additional skills that the other party brings to the enlarged business.

Neil Clark, Chief Executive Officer of PrimeVigilance Ltd, commented: 

“This synergistic combination of PharmInvent with PrimeVigilance creates a business with a market-leading position in the provision of outsourced pharmacovigilance services for clients developing or selling drug products across the world. The enhanced service offering and mutual focus on high quality will ensure that existing and new clients continue to receive the best advice and service”.

Jan Petracek MD, Chief Executive Officer of PharmInvent, said:

“These are very exciting times for PharmInvent. We have spent the last six years building our business and reputation and now look forward to significantly leveraging our position working alongside PrimeVigilance. Together, our skills will allow us to seize significant new opportunities as well as expand our offering to our existing customer base. “

PharmInvent will continue to be led by its founders, Dr Jan Petracek and Dr Martin Votava. Dr Petracek was formerly a Head of the Risk Management Section at the European Medicines Agency (EMA), while Dr Votava represented the Czech Republic in the Committee for Medicinal Products for Human Use at the EMA.

CEO of PharmInvent, Dr Jan Petracek, will join the Board of PrimeVigilance. Neil Clark, CEO of PrimeVigilance, will join the Board of PharmInvent.

In addition, Dr Jan Petracek has been appointed as non-executive director and President of PrimeVigilance.

– END –

About PrimeVigilance

 PrimeVigilance is a Pharmacovigilance (PV) and Medical Information Services company with an established international footprint and a heritage of excellence and leadership in the field of pharmacovigilance.

PrimeVigilance was established in 2008 and offers comprehensive, top quality, cost-effective, innovative safety services for pharmaceutical, generic and biotechnology companies. Our founders have an unrivalled reputation in the sector with a network of expert associates across the world. These include former senior regulators and consultants with extensive industry experience, especially with marketed products.

Expert pharmacovigilance services

The pharmacovigilance services offered by PrimeVigilance cover all the regulatory and scientific elements of PV required to obtain and maintain a product licence within Europe: Qualified Person, Risk Management Planning (RMP), and a compliant PV System with consistent Adverse Event data capture, robust Quality Management, expedited reporting, preparation of PSURs, literature screening, signal detection and evaluation, benefit-risk assessment, compliance auditing, support during crisis and various ad hoc assignments. PrimeVigilance also offers fully integrated international Medical Information service.

PrimeVigilance specialises in helping emerging companies comply with regulations, from developing the initial PSMF and RMP to full management of safety operations.

A global reach

PrimeVigilance has grown organically since 2008 and now has over 250 staff employed in its four main offices in Guildford UK, Zagreb, Croatia, Boston, USA and Belgrade, Serbia. As well as an international network of consultants .PrimeVigilance is currently providing services across 100 countries.

For more information contact PrimeVigilance today

About PharmInvent

PharmInvent provides high quality and value-for-money services in pharmacovigilance, pharmaceuticals risk management, regulatory science and clinical development to the pharmaceutical industry, contract research organizations, academia, the healthcare industry, and national government organizations. PharmInvent has achieved global geographical coverage focusing on ICH regions, and operates ISO 9001:2015 certified quality management system.

PharmInvent‘s specialists share their insights and expertise at training courses, seminars and conferences organized by international pharmaceutical societies on 4 continents. They have trained thousands of industry professionals on the best practices in pharmacovigilance and regulatory compliance and have cooperated closely with numerous regulatory agencies around the world.

PharmInvent has grown organically since 2010 and now totals over 60 employees along with an international network of about 90 PV experts from over 50 countries. The management of PharmInvent consists of pharmacovigilance and regulatory experts with vast experiences from the European Medicine Agency, National Competent Authorities, and the pharmaceutical industry. To learn more about PharmInvent and the services offered, please visit .

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