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Services

End-to-end services for high-quality safety and pharmacovigilance operations

Benefit-Risk Management

Case Processing

Safety Systems and Reporting

QPPV and PSMF

Local Contact Person for Pharmacovigilance

GVP Audits/Inspection Preparedness

Medical Information Services

Safety and Medical Writing

Literature Surveillance

Signal Management

Pharmacoepidemiology

Medical Monitoring

Clinical Trial Safety Committee Management

Safety Management Plan

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Solutions

Technology-driven solutions integrated into the pharmacovigilance landscape

PVConsult™

Optimise your PV operations through monitoring and use of technology by our SMEs.

PVTransition™

Come to rescue of your PV systems during service provider modifications or technology switch.

PVBridge™

Help our long-standing clients to develop in-house pharmacovigilance capacity.

PVIntegrate™

Streamline your PV systems and processes during expansion.

PVExpert™

Strengthen your negotiations with regulators, HTAs and external stakeholders.

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Product Expertise

Product expertise which enables efficiencies in PV operations

Innovative/Brand Products

Support the development of PV plans and risk minimization measures pre- and post-marketing.

Generics, Hybrids, Biosimilars

Methodical management of challenging PV agreements, signal detection, audits schedules & conduct and training.

Vaccines

Comprehensive PV management of seasonal vaccines ICSRs and systems to enable seamless end-to-end operations.

Devices and Combination Products

Our experts can advise you on your vigilance system, post-market surveillance and safety reporting.

Pediatric Medicines

Support tailored PV research in pediatrics and draw lessons from risk minimization of ARs in adult population.

Medicines for Older People

We adjust your RMPs cognizant that co-morbidities or side effects - specific to older patients - will shape PV activities.

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Insights Hub

Latest Case Studies

Quality & CAPA Management

Overview of the ISO Identification of Medicinal Products (IDMP) Standards

Published: 21 February, 2023

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Webinars

Latest Webinar

Exploring the Crucial Role of Local Persons for Pharmacovigilance on a Global Scale

The essential role of local person in ensuring effective pharmacovigilance worldwide

Published: 4 May, 2023

Duration: 19 Mins

More webinars

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News and Events

News

Register for Latest Ergomed Group Webinar on Vendor Management

Published 24 July 2023

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Events

World Drug Safety Congress Americas 2023 | Boston, MA, USA

Published 20 September 2023

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News – New PrimeVigilance Hot Topic Webinar: EVDAS Outputs are Available to MAHs – What Now?

Key topics covered in this webinar include:
• How to plan signaling frequency
• What sources of data need to be considered
• What best to focus on during signal detection vs. signal evaluation reviews
• The robust documentation of activities
Finally this webinar will focus on giving the listeners a comprehensive overview of all the new regulatory requirements for products on an additional monitoring list, and some last-minute additional requirements for other products that were not expected to be impacted by EVDAS during 2018.
The webinar will be followed by a Q&A session where you will be able to ask questions and receive direct feedback on key areas of uncertainty.
Click here to book your place today. If you require further information, please do not hesitate to contact us.