Frequently Asked Questions
Everything you need to know before choosing PharmAdvice as your regulatory and pharmacovigilance partner in the Nordics.
Experience
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We specialise in guiding small and mid-sized pharmaceutical companies safely through the complex regulatory postmarketing process across Denmark, Iceland, Norway and Sweden, efficiently steering clear of compliance risks to ensure patient safety.
Our services are tailored to companies entering the Nordic markets or looking to strengthen their existing regulatory setup for medicine, herbal medicine and food supplements.
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We have 20 years’ worth of in-depth knowledge of national procedures, requirements and expectations, including Danish Medicines Agency requirements, EMA standards and Nordic market adaptations. Our guidance aligns with local frameworks and legislation.
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PharmAdvice has more than 20 years of experience within regulatory affairs and pharmacovigilance. We are a privately owned Danish company with long-standing relationships in the pharmaceutical sector. Our clients continue to put their trust in us due to the consistency and high quality of our work.
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Our services can scale up and down with your business needs. We regularly support clients through new product launches, expansions and new market entries. Through our solid network of trusted partners across the EU, we can assist you when entering markets in the Nordic countries and beyond.
We and our partners ensure that you adhere to all local requirements while supporting your international strategy.
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Our consultants advise on general GVP and GDP compliance in the EU and local legislation and best practice in Scandinavia. For specialised local expertise in other EU countries, we rely on our extensive network of international pharma compliance service providers.
Collaboration
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Working with us is much like working with internal resources but without the employer obligations and fixed cost. You will have one dedicated contact person who gets to know your organisation like their own and who is easy to reach for questions and meetings.
In other words, you get the flexibility and expertise of an external contractor and the trust and close collaboration of an employee.
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We start with a brief consultation to assess your needs. From there, we provide a clear onboarding plan and a proposed timeline. Most partnerships are up and running within a few weeks.
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We begin with a structured onboarding, mapping your needs and defining responsibilities. From there, we implement clear workflows and reporting lines, ensuring predictability and full compliance throughout the process.
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We charge by the hour and adapt our solutions to your organisation’s specific needs. There are no hidden fees, and all agreements include a detailed overview of scope, deliverables and responsibilities, so you know exactly what you are paying for.
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Yes. We are based in Denmark and understand both the local market and regional nuances across the Nordics. We work closely with partners in the other Nordic countries – Denmark, Norway, Sweden and Iceland – and offer support in English and the local language where needed.
Compliance
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Our services are based on current GVP and GDP guidelines, with detailed SOPs, continuous training and quality assurance embedded in every process. We also assist with audit readiness, deviation handling and CAPA systems, if required.
We run internal audits every three years and submit to MAH audits as required. In addition, we offer our clients access to a joint PV audit report by an independent auditor.
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We treat all client data with confidentiality. Our systems comply with GDPR and industry best practices, and we sign NDAs with all clients and partners.
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Yes, our QPPV is medically trained.
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We work with validated tools and follow documented SOPs. All processes are clearly described, and you will have access to regular reports, documentation and follow-up as needed.
Our quality management system (QMS) adheres to the extensive documentation requirements of the EUs Good Distribution Practice (GDP) guidelines. If required, we can work in your existing QMS as well.
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We have clear procedures for deviation handling and corrective actions. In case of any issues, we act quickly, documenting, resolving and preventing further incidents through our structured CAPA system.
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No, the Danish Medicines Agency does not generally require you to nominate a PV contact person in Denmark. However, in their own words, they may do so if “it is considered necessary”. Nor do you need a local PV contact person in any of the other Scandinavian countries.