The benefits to the business in rigorous GDP compliance are multiple: In addition to maintaining the licence to operate, compliance with quality parameters are an efficient management tool.

However, as an RP through more than 20 years I have noticed that pharma companies and their supply partners often overlook four essential elements of the GDP work.

In May 2026, PharmAdvice will host the annual EuDRAcon conference in Copenhagen as part of its one-year chairmanship of the pan-European regulatory network.

The conference will bring together independent regulatory service providers from across Europe to discuss developments within regulatory affairs, pharmacovigilance, market access, and related compliance areas.

PharmAdvice awarded Bronze in the 2026 EcoVadis sustainability rating

Since the first evaluation last year, PharmAdvice has worked systematically to further formalise and document its sustainability efforts. This has included the implementation of more detailed SOPs, the establishment of concrete objectives, and improved traceability in the way progress is measured and reported.

Many smaller pharma companies and distributors struggle to establish a compliant QMS.

Even more struggle to make the system a useful management tool in day-to-day operations.

An outdated or poorly embedded QMS is not just a GDP compliance issue. It is a competitive risk and, at worst, a patient safety liability.

The European Commission has amended the regulation governing pharmacovigilance practices. Here is what those changes mean for you as an MAH and which steps to take to comply with the updates.

In this article, you will find a list of the most common ongoing and annual pharmacovigilance activities and the documentation you should provide for each activity.

This article outlines six overlooked reasons why full insourcing rarely supports long-term cost control, quality, or compliance, and why outsourcing to a trusted partner may, in fact, be the most responsible path forward.

An international pharmacovigilance client recently needed our assistance facilitating an inspection with inspectors from three Scandinavian countries.

At PharmAdvice, we review our business continuity plan (BCP) annually. But prompted by recent international events, we have given it a comprehensive re-evaluation to ensure it’s aligned with all relevant risks and threats.

In January 2025, PharmAdvice achieved a “Committed” rating in our first EcoVadis sustainability assessment with a score of 57 out of 100.

We are currently working towards achieving an EcoVadis bronze medal.

A risk-based audit should cover governance, risk management and internal controls of all parts of the pharmacovigilance system, as well as pharmacovigilance activities delegated to another organisation such as PharmAdvice, and you should assess risks at both the strategic, the tactical and the operational level.

Are you planning for a Good Distribution Practice (GDP) audit, but lack the time or qualifications? At PharmAdvice we act on behalf of our customers as external Responsible Person and regularly perform GDP audits on their behalf.

I am happy to announce that Tina Nørgaard has joined PharmAdvice as Marketing Compliance and QA Manager.

Tina Nørgaard is a pharmacist with a Master in public administration and more than 30 years of experience within the pharma industry.

The regulatory procedures for renewal applications for Mutual Recognition Procedures (MRP) and Decentralised Procedures (DCP) have been simplified with the publication of the CMDh update of the Best Practice Guide for renewals in February 2023.

I am happy to announce that Christina Guiton has joined the PharmAdvice pharmacovigilance team as QPPV and pharmacovigilance manager.

Christina Guiton is a medical doctor with more than 20 years of experience within the pharma industry.

On 22 November 2017, EMA launched the new EudraVigilance system. All marketing authorisation holders (MAHs) were required to monitor EudraVigilance data with a start date of 22 February 2018.
In August 2022 EMA and the European Commission agreed to further extend the pilot until the end of 2023.

In all marketing compliance materials, the word "new" or words indicating that a medicinal product is new can only be used for a limited period of time.

As of 28 January 2022 organisations must verify that their relevant locations (company name and location address details) are correctly recorded in OMS.

We have included the link to use for PRAC recommendations and PI translations, listed in chronological order including the option of choosing languages other than English.