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Pharmacovigilance Services

"WE CARE
ABOUT YOUR SAFETY"

The regulatory requirements for drug safety monitoring are becoming more complex within the ICH regions. As a result, pharmaceutical companies need to devote ever greater resources and budget to manage their compliance with pharmacovigilance regulatory requirements.

At APC Europe, We have a team of Pharmacovigilance experts who can provide a complete range of services using the latest state of the art technology.

This service is based on a fully electronic platform which is compliant with the International Conference of Harmonization, ICH–E2B (EU) and 21 CFR part 11 (US-FDA) regulatory requirements. This is further supported by a trained and dedicated pharmacovigilance team managed by people who have extensive experience and expertise in managing drug safety compliance.

The ability to provide excellent quality services at highly competitive prices is what gives APC Europe an edge over other CROs.

APC Europe’s pharmacovigilance services business provides a platform for European and US pharmaceutical companies including innovator companies where clinical trial pharmacovigilance is required.

We offer the following pharmacovigilance services:

The Establishment of US and EU-Regulatory Compliant Pharmacovigilance Systems

We have invested in an infrastructure that means we can operate as the US or EU hub for our clients. This service can be operated either by accessing the global software of the client or by setting up and validation of a new software database which is dedicated for the client. We can compile company standard operating procedures for Pharmacovigilance for the client and also undertake data entry, analysis, review and electronic submission of Individual Case Safety Reports, as well as, 7- or 15- day MedWatch alerts.

Reporting of Individual Case Safety Reports / 7-day and 15-day MedWatch alerts

As a part of this service as an EU-hub for Pharmacovigilance, we can operate as the central contact point within the EU and the US for all safety related queries and complaints. Any Adverse Reaction reports received can then be entered into the safety database, analysed in terms of seriousness, reportability and causality. Reportable cases are then reported to the different regulatory agencies electronically within the prescribed timelines.

Literature search

We can also undertake literature searches on a weekly basis for client’s products and report these on their behalf to the regulatory agencies.

QP Services

We offer the services of ‘Responsible Person/Qualified Person for Pharmacovigilance’ within the US or EU including managing inspections by the FDA/EU Regulatory Agencies. The QP can oversee the complete process for Pharmacovigilance including management and monitoring of regulatory compliance.

PSUR/Periodic Report submission

We can manage the complete process for the compilation and submission of Periodic Reports/Periodic Safety Update Reports including generation of literature searches, compilation of expert reports, sign off of the periodic report/ PSURs by a medically qualified person and submission to FDA/ EU-regulatory agencies.