Elliot Brown Consulting and Ergomed CRO have launched PrimeVigilance, a new pharmacovigilance services company. Founded by two globally respected experts, the newly formed PrimeVigilance Ltd. provides a unique offering in the field of pharmacovigilance, more here...
Founded by two globally respected experts, the newly formed PrimeVigilance Ltd. provides a unique offering in the field of pharmacovigilance (PV).
PrimeVigilance specialises in helping emerging and established companies to comply with regulations, from full management of safety operations to specialist consulting. Its comprehensive services cover all the regulatory, medical and scientific elements of PV required to obtain and maintain a product licence within Europe, including:
Detailed Description of PV System
Validated ARISg safety database
A compliant PV System with robust Quality Management, consistent: adverse event data capture and expedited reporting, preparation of PSURs, literature screening, signal detection and evaluation, benefit-risk assessment, compliance auditing, risk management planning, support during crisis, etc.
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 UK-registered multinational company which provides an innovative, top quality and cost-effective safety operation for small- and medium- sized 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 top-level, 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 middle-East, the Ergomed Group is a quality-focused 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 post-marketing 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.
For more details visit www.primevigilance.com or contact PrimeVigilance at....Phone: +44 (0) 1483 688 349
Fax: +44 (0) 1483 688 348
Elliot Brown Consulting Ltd
Registered Office:
Russell House,
140 High Street,
Edgware,
Middlesex HA8 7LW
Registered in
England and Wales.
Reg No. 3691390