About PharmAdvice
PharmAdvice: Your efficient postmarketing specialist in Scandinavia
PharmAdvice is a Danish consultancy with more than 20 years of experience in regulatory compliance and pharmacovigilance for medicinal products in Scandinavian markets.
We specialise in guiding small and mid-sized pharmaceutical companies safely through the complex regulatory postmarketing process, efficiently steering clear of compliance risks to ensure patient safety.
Our services
Whether you need a permanent outsourcing partner or interim assistance, our experienced postmarketing compliance specialists ensure that your company adheres to all relevant standards and regulations in Scandinavia and the EU.
Pharmacovigilance
Our pharmacovigilance consultants manage your PV operations and PV system in the EU.
Regulatory Affairs
Our regulatory affairs consultants ensure regulatory compliance of pharmaceutical products.
Marketing Compliance
Our industry experts align the marketing of your medicinal products, herbal medicines, or food supplements with EU legislation.
Quality Compliance
Our quality management consultants help you navigate the Good Distribution Practice (GDP) guidelines and set up your QMS.
Why we are a safe choice for you
Competent team of specialists
Our team of senior specialists work with a wide range of market leading companies, and we share our knowledge with our clients to develop and optimise the right services for you. The team includes medically trained consultants to ensure appropriate safety handling, e.g., clinical assessments of safety information and health hazard evaluations.
With our experience and know-how, efficient compliance becomes an integral part of your business strategy.
Local knowledge, Nordic focus
With more than 20 years of experience with pharmacovigilance and regulatory compliance in the pharmaceutical industry in Scandinavia, the EU and EEA, our understanding of national requirements and local differences between Denmark, Norway and Sweden is profound.
Through our solid network of trusted partners, we can assist you when entering markets in the other Nordic countries as well. We and our partners ensure that you adhere to all local requirements while supporting your international strategy.
A flexible part of your organisation
Working with us is much like working with internal resources but without the employer obligations and fixed cost.
We charge by the hour and adapt our solutions to your organisation’s specific needs. 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.
Wide network in the EU
Despite being a small team, we can easily scale your solution as needed. After 20 years in the industry and as part of the pan-European network EuDRAcon, we can draw on trusted, local postmarketing compliance providers in all EU countries.
Always up to date on regulations and systems
We stay up to date on the current guidelines and training as well as EU and local regulations, databases and software. We attend annual seminars, network events and conferences and stay up to date on changes to the EMA’s databases to maintain efficient data management.
The process: 3 simple steps to compliance
We strive to make pharmacovigilance and regulatory compliance a simple and safe process for pharmaceutical companies. Our straightforward and responsible approach ensures that you comply with all regulatory requirements without being weighed down by unnecessary bureaucracy.
We define your requirements
We discuss and analyse your requirements, drawing a full picture of your compliance needs and strategic opportunities.
We tailor the solution
We present a plan of action based on our more than 20 years of experience and our tried and tested systems and operating procedures, ensuring that regulatory compliance is an integral part of your business strategy.
We adjust regularly
At least once per year, we sit down with you to discuss your plans and aims for the marketing of your products. This allows us to adjust the use of resources, mitigate any compliance risks and plan specific actions.