Comprehensive Pharmacovigilance Services

Allurmed provides comprehensive pharmacovigilance services to pharmaceutical manufacturers, marketing authorisation holders, distributors and other life sciences organisations.

Pharmacovigilance is the continuous monitoring, collection, assessment, documentation and management of information related to the safety of medicinal products before and after registration.

Allurmed supports companies in establishing and maintaining effective pharmacovigilance systems, managing adverse event reports, preparing safety documents and fulfilling applicable local regulatory obligations.

Our services are individually adapted to the regulatory requirements of the relevant countries, the company’s product portfolio and its pharmacovigilance needs.

Our core pharmacovigilance services

• provision of a local pharmacovigilance responsible person;

• adverse event intake and case management;

• preparation and management of Individual Case Safety Reports — ICSRs;

• local and global scientific literature monitoring;

• preparation of PSUR and PBRER reports;

• preparation and maintenance of Risk Management Plans — RMPs;

• preparation and maintenance of the Pharmacovigilance System Master File — PSMF;

• safety signal detection and assessment;

• continuous benefit–risk evaluation;

• preparation of pharmacovigilance standard operating procedures;

• preparation and review of SDEAs and pharmacovigilance agreements;

• safety review of product information;

• management of regulatory authority requests;

• pharmacovigilance audits and CAPA management;

• pharmacovigilance training for employees and partners;

• full or partial pharmacovigilance outsourcing.

Why Allurmed?

Allurmed approaches pharmacovigilance as an integrated and continuous drug-safety system rather than a collection of separate reporting activities.

For each project, we develop an individual service model based on the product safety profile, registration status, applicable national requirements and the company’s internal procedures.

Professional pharmacovigilance support helps companies fulfil their regulatory obligations, identify emerging safety risks and protect patients.

Contact Allurmed to establish, improve or outsource your pharmacovigilance system.