We help emerging and established companies meet their regulatory obligations.
PrimeVigilance, an Ergomed Group company, was established in 2008 by Dr. Miroslav Reljanovic together with co-founder Dr. Elliot Brown. PrimeVigilance oﬀers holistic, top quality, cost-eﬀective, innovative safety services for pharmaceutical, generic and biotechnology companies. Our founders and leaders 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.
We are recognised for the quality of our services and the professionalism of our team.
PrimeVigilance has grown organically since 2008 and we now have over 900 people working from our seven main offices in the United Kingdom, United States, Croatia, Czech Republic, Germany, Poland, Serbia and Japan. Our pharmacovigilance services cover all the regulatory and scientific elements required to obtain and maintain a product licence. PrimeVigilance also offers fully integrated international Medical Information, Pharmacoepidemiology and Benefit-Risk Management services. PrimeVigilance specialises in helping emerging companies comply with regulations, from developing the initial Detailed Description of PV Systems and RMP right through to full management of safety operations.
OPERATIONAL LEADERSHIP TEAM
Meet the people behind PrimeVigilance
PrimeVigilance is a subsidiary of Ergomed plc. and is managed by its own Board of Directors which includes leading pharmacovigilance experts
CORPORATE SOCIAL RESPONSIBILITY
Contributing toward a better world
PrimeVigilance recognises that its activities and operations have a societal impact and we place a high emphasis on our social responsibilities.
“Thank you for such amazing support – we could not have done this without you! Your team’s dedication, quick turnaround, subject matter expertise, and kindness are to be recognized! Thanks for your continued commitments to quality.”
Clinical Quality Leader
Mid-size US biotech company developer of gene therapy treatment
“It has been a pleasure working with you, having your expertise and prompt support with our literature search activities – all much-much appreciated!”
Group Medical Director, Medical Safety Review Worldwide Patient Safety (WWPS)
Large worldwide Pharmaceutical company
“I’ve been most impressed by your quarterly safety detection methods and would like to incorporate them for other studies I am responsible for.”
Chief Medical Officer
“I wanted to write to you to let you know of the excellent help and support we received prior to and during the Inspection by members of the PrimeVigilance team.”
Senior Quality Assurance Manager
Swiss Pharmaceutical Company
“We sincerely thank you all for your help and successful labor during this year and we are looking forward to work with you as well in the future.”
Head Safety Processes Manager
Global Drug Safety Section
“Knowing I have you as partners helps me sleep soundly at night.”
CMO and Director of Compliance
PBRERS, PADERs, DSURs, ACOs, RMPs written per year