UK +44 (0)1483 503 205
US +1 (919) 401 8003
info@primevigilance.com

Our Company

About us

About PrimeVigilance Why PrimeVigilance? Executive Leadership Team Operational Leadership Team Our Mission, Core Values and Vision PrimeVigilance Corporate Social Responsibility Statement Download PrimeVigilance Brochure Download Ergomed Brochure

Get in touch

Ergomed Group Sites

Ergomed Corporate Site Ergomed Clinical Research Site

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

Project Management

Services Homepage

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.

See all Solutions

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.

Learn more

Insights Hub

Latest Case Studies

Quality & CAPA Management

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

Published: 21 February, 2023

More case studies

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

Visit Insights Hub

News and Events

News

Navigating the Latest Revisions in GVP: Key Updates on Module XVI and Risk Minimization Measures

Published 24 September 2024

View all News

Events

World Drug Safety Congress Americas 2024

Published 25 September 2024

View all Events

See all News and Events

8 July, 2024

From XEVMPD to PMS: How ISO IDMP Standards are Revolutionizing Medicinal Product Data Management

Insights Hub

XEVMPD has supported EU pharmacovigilance by providing an up-to-date medicinal product repository, however, global standardization through ISO IDMP standards is needed for better data exchange. ISO IDMP ensures clear communication and interoperability in healthcare and regulatory environments.

The EMA is transitioning to ISO IDMP with the implementation of SPOR master data domains. From May 2024, MAHs and NCAs have read-only access to product data in PMS. MAHs should review and enrich their data to meet ISO IDMP standards by December 2025.

Download Here