Regulatory affairs consulting services:

Experienced PV consultants for EU and Scandinavian markets

Our team of trained and experienced pharmacovigilance consultants can help you manage your pharmacovigilance operations in the EU. We specialise in pharmacovigilance for medicinal products marketed in Scandinavia.

Safely navigate European pharmacovigilance legislation – also at the national level

Are you entering the Scandinavian markets and need help understanding and implementing national pharmacovigilance legislation for your medicinal product?

With PharmAdvice as your pharmacovigilance service provider, you ensure an effective pharmacovigilance system specific to the Scandinavian countries, ultimately protecting patient safety right down to the national level.

Pharmacovigilance safety for small and large enterprises

We are an independent Danish pharmacovigilance consultancy company specialising in helping pharmaceutical companies who are marketing medicines in Denmark, Norway and Sweden. We also facilitate your PV efforts in other Nordic countries through our extensive network of qualified, local subcontractors.

Our clients are pharmaceutical enterprises of all sizes, from start-ups to established businesses and multinational companies. The common denominator is their wish to ensure patient safety, regulatory alignment and inspection readiness.

Pharmacovigilance consulting adapted to your needs

PharmAdvice’s PV consultants have extensive experience with every aspect of pharmacovigilance.

Whether you need someone to step in and substitute or support your in-house pharmacovigilance team or someone to manage your drug safety activities in Scandinavia, they have the expertise you need.

Contact us to learn how we can help you:

PharmAdvice-pharmacovigilance-experts

Experienced pharmacovigilance experts

Our consultants are all trained pharmacovigilance professionals and experienced in all aspects of pharmacovigilance. We also have medical staff on the team.

Your PV contact person in Scandinavia

Our extensive knowledge of pharmacovigilance and medicinal product legislation in Scandinavia makes us the safe choice as your local PV contact person.

Joint service provider audits

As a client, you can buy in to an independent joint audit of our pharmacovigilance services and save time and money on service provider audits.

Fully compliant PV quality system

We can work according to your PV quality system, or you can save time and money with our compliant and updated PV system running under PharmAdvice quality operations.

“We rely on PharmAdvice to help us stay compliant and to notify us early if any adjustments are needed. This helps us maintain our license to operate in key markets like Scandinavia and the EU – with additional support from their network of service providers. And we rely on PharmAdviceʼs medical consultant in matters of adverse events globally,ˮ says Kristian Uggerhøj.

Client: Kristian Uggerhøj, CEO, Alkalon A/S
Services: Pharmacovigilance, Regulatory Affairs
Collaboration: 2011-

Pharmacovigilance services pre- and post-marketing

  • We provide a summary of the pharmacovigilance system for your marketing authorisation application. Based on your customer inputs, we develop the pharmacovigilance system master file (PSMF) in compliance with the European Medicines Agency’s guidelines on Good Pharmacovigilance Practices (GVP and build a risk management plan (RMP).

  • Our consultants register your MAH profile in EudraVigilance, create and manage your medicinal products in the EU product database (XEVMPD, aka Article 57 database) and submit safety and product reports to the system as needed.

  • You have 24-hour access to an EU qualified person for pharmacovigilance (QPPV), who is medically trained. The QPPV ensures that the safety of medicinal products is continuously monitored and managed in accordance with regulatory requirements as mandated in the EMA’s GVP guidelines for marketing authorisation holders.

    Learn more about our QPPV, LPPV and deputy QPPV services.

  • Our consultants assist you in writing procedures for your in-house pharmacovigilance system to ensure compliance with European and local legislation. For start-ups and companies with a limited scope of PV SOPS, our PV quality management system (QMS) supplements the required internal SOPs for handling adverse event reports and PSMF.

  • We help create your mandatory risk management plan (RMP) with the medicine’s safety profile and plans for pharmacovigilance activities. The RMP outlines how risks to patients are minimised and how those efforts are measured. We also help with the national execution of additional risk management activities such as educational materials and patient cards.

  • Our trained PV consultants collect data on medicine safety by handling adverse event reports from the market, post-marketing studies, EudraVigilance, EMA’s medical literature monitoring (MLM), and by surveying local and global scientific literature.

  • Our consultants monitor for known and new safety issues, create and evaluate drug-adverse event reports, and prepare signal management reports documenting that you are monitoring the safety profile of the medicinal product.

  • We prepare periodic safety update reports (PSUR) for you. We also handle the health authority interface, submissions through the PSUR portal, and band responses to questions from the local competent authorities.

  • Our consultants help your organisation become inspection-ready by performing pre-inspection PV system reviews and drafting a plan for managing any deficiencies. They can also support your staff during inspections, plan responses to relevant authorities and assist you in resolving any findings.

  • Our pharmacovigilance consultants may substitute for your internal drug safety personnel and assist less experienced staff with medical and pharmacovigilance expertise on a temporary basis.

  • We handle and translate medical information queries in Scandinavia.

Contact us to learn how we can help you: