About
PrimeVigilance

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 800 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.

“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

Specialty Pharma

“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

Pharmaceutical Company

>1,500

PBRERS, PADERs, DSURs, ACOs, RMPs written per year

>900,000

Literature abstracts reviewed yearly

>300,000

ICSRs/SAEs processed every year

>600

Signal evaluation reports prepared every year

>42

PSMFs drafted of which 34 managed in-house

>40,000

Medical information inquiries received per year

Submit RFI/RFP

+44 (0)1483 307920
(+1) 781 703 5540

LOCATIONS

United Kingdom (Head Office)

PrimeVigilance Ltd
1 Occam Court
Surrey Research Park
Guildford, Surrey
GU2 7HJ

USA

PrimeVigilance USA Inc.
100 Regency Forest Drive
Suite 160
Cary
NC 27518 USA

Croatia

PrimeVigilance Zagreb d.o.o.
Oreskoviceva 20A
10020 Zagreb

Germany

PrimeVigilance GmbH
Herriotstr. 1,
60528,
Frankfurt am Main

Czech Republic

PrimeVigilance s.r.o.
Stetkova 18
140 00 Praha 4

Serbia

PrimeVigilance d.o.o. Beograd
Đorđa Stanojevića 14
11070 Novi Beograd

Poland

PrimeVigilance –
Ergomed Sp. z.o.o.
Ul. Armii Krajowej 18
30-150 Krakow

Japan

PrimeVigilance Japan K.K.
3-1-6 Motoazabu, Minato-ku,
Tokyo, Japan

About
PrimeVigilance

We help emerging and established companies meet their regulatory obligations

Ensuring a world with safer drugs

OUR MISSION

We are recognised for the quality of our services and the professionalism of our team

OPERATIONAL LEADERSHIP TEAM

Meet the people behind PrimeVigilance

+

CORPORATE SOCIAL RESPONSIBILITY

Contributing toward a better world

+

“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)

“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

“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

“Knowing I have you as partners helps me sleep soundly at night.”

CMO and Director of Compliance

>1,500

PBRERS, PADERs, DSURs, ACOs, RMPs written per year

>900,000

Literature abstracts reviewed yearly

>300,000

ICSRs/SAEs processed every year

>600

Signal evaluation reports prepared every year

>42

PSMFs drafted of which 34 managed in-house

>40,000

Medical information inquiries received per year

Discover how we can help you

CONTACT US

About PrimeVigilance

We help emerging and established companies meet their regulatory obligations

Ensuring a world with safer drugs

OUR MISSION

We are recognised for the quality of our services and the professionalism of our team

OPERATIONAL LEADERSHIP TEAM

Meet the people behind PrimeVigilance

+

CORPORATE SOCIAL RESPONSIBILITY

Contributing toward a better world

+

“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)

“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

“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

“Knowing I have you as partners helps me sleep soundly at night.”

CMO and Director of Compliance

>1,500

PBRERS, PADERs, DSURs, ACOs, RMPs written per year

>900,000

Literature abstracts reviewed yearly

>300,000

ICSRs/SAEs processed every year

>600

Signal evaluation reports prepared every year

>42

PSMFs drafted of which 34 managed in-house

>40,000

Medical information inquiries received per year

Discover how we can help you

CONTACT US

About
PrimeVigilance