About PrimeVigilance
Prime Vigilance is a pharmacovigilance (PV) services company with an established international footprint and a heritage of excellence and leadership. Set up as a joint venture between Drs. Elliot Brown and Miro Reljanovic, the company offers a comprehensive, top quality, cost-effective, innovative safety operation for pharmaceutical and biotechnology companies. Dr.Brown’s existing consultancy, Elliot Brown Consulting (EBC), has an enviable reputation of a decade in PV, with a network of expert associates spanning 3 continents, These include former senior regulators and consultants with extensive industry experience, especially with marketed products.
Dr.Reljanovic’s CRO, Ergomed, with offices in the UK, Germany, Southern and Eastern Europe, Russia and the middle-East is a quality-focused organization with outstanding staff and several years experience with the ARISg safety database. This brings an experienced operational dimension that will draw on top-level consultancy support from EBC.
The services 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 so on.
PrimeVigilance specialises in helping emerging companies comply with regulations, from developing the initial Detailed Description of PV System and RMP to full management of safety operations.
For more information contact PrimeVigilance today