Post Marketing – Pharmacovigilance

Comprehensive, Compliant and Customised solutions

Pharmacovigilance & Patient Safety:

Post marketing surveillance is monitoring the safety of a pharmaceutical drug or medical device after it has been released on the market and is an important part of the science of pharmacovigilance.

From versatile technologies and targeted data collection and analysis to in-depth reporting and regulatory compliance, we provide a comprehensive range of pharmacovigilance services throughout the product life cycle to detect, assess, understand, and prevent adverse effects or any other drug-related issues, compliant with EMA, FDA and ICH, ultimately making patients’ lives better.

We ensure that this is a comprehensive yet cost-effective process, enabling full compliance with legal requirements. We have a team of fully qualified medical professionals acting as QPPV’s with with European, US or Global coverage.

Comprehensive, Compliant and Customised solutions

At the heart of our commitment to patient safety lies a robust pharmacovigilance ecosystem – designed to support every phase of the product lifecycle. Whether you need an end-to-end solution or a region-specific service, our flexible model is built around your product portfolio and regulatory landscape.

Our services are delivered through strategically located offices in the UK and the Netherlands, supported by a global team of pharmacovigilance experts, offering a truly global reach with local expertise.

Build your safety strategies with us
Whether launching a new molecule or maintaining post-marketing surveillance, we’re here to support you with scalable, compliant, and expert-led pharmacovigilance solutions.

Ready to elevate your safety systems?
Contact our PV Team

 

Steps

MICC (Medical Information Contact Center)

Providing responsive and compliant medical information support to healthcare professionals, patients, and stakeholders through trained pharmacovigilance personnel.

Global and Local Literature Monitoring

Comprehensive monitoring and review of global and local scientific literature to identify and evaluate potential safety information related to medicinal products.

Case Management

End-to-end adverse event case processing services including data entry, medical coding, quality review, and regulatory reporting in compliance with global regulations.

Periodic Safety Reports

Preparation, review, and submission support for aggregate safety reports including PADERs, PSURs, PBRERs, DSURs, Annual summary reports, and other regulatory safety documents.

Signal Management

Proactive detection, evaluation, and management of safety signals to support continuous benefit-risk assessment of products.

Risk Management Plan

Development and maintenance of Risk Management Plans (RMPs) aligned with regulatory expectations and product safety requirements.

Global Submissions

Timely preparation and submission of safety reports to global regulatory authorities in accordance with regional regulatory requirements.

Regulatory Intelligence

Continuous monitoring and interpretation of evolving pharmacovigilance regulations to support regulatory compliance and strategic decision-making.

[bold_timeline_item_button title=”Expand” style=”” shape=”” color=”” size=”inline” url=”#” el_class=”bold_timeline_group_button”]
Category:
Services
Service:
Pharmacovigilance