Single point of contact makes PV and RA manageable and coherent for Alkalon A/S

For over a decade, PharmAdvice has been a trusted partner for Danish pharmaceutical company Alkalon A/S, delivering expert support in both regulatory affairs (RA) and pharmacovigilance (PV). This collaboration ensures Alkalon remains compliant in an evolving regulatory landscape while benefiting from flexible capacity and cost-effective expertise.

With a single point of contact and actionable regulatory guidance, PharmAdvice enables Alkalon to focus on strategic and commercial decisions rather than operational details, which has resulted in a long-term partnership founded on credibility and trust.

A practical partnership built on trust

As a smaller pharmaceutical company, Alkalon operates in a highly regulated environment where compliance and timely action are essential. For the past 14 years, PharmAdvice has supported Alkalon with regulatory affairs and pharmacovigilance.

 According to CEO Kristian Uggerhøj, this dual-service setup makes the work more manageable and coherent:

“We need a partner that understands the bigger picture. Someone who can identify what matters, so we don’t have to be deep in the details ourselves. That’s the role PharmAdvice plays for us.”

Adapting to changing workloads

One of the main advantages of working with PharmAdvice, according to Alkalon, is the flexibility in both capacity and competence. As the workload in regulatory affairs and pharmacovigilance fluctuates, the team at PharmAdvice adjusts accordingly, ensuring that Alkalon always meets current regulatory requirements while staying aligned with strategic commercial decisions.

“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 PharmAdvice’s medical consultant in matters of adverse events globally,” says Kristian Uggerhøj.

Transforming complex rules into clear guidance

A key benefit for Alkalon is PharmAdvice’s ability to translate regulatory complexity into clear, actionable insights with an understanding of the commercial and strategic objectives of the business. Kristian especially appreciates the Key Account Manager setup:

“Having Susanne Ølsgaard Felumb as our single point of contact is incredibly valuable. She helps us navigate a complex field without us having to talk to multiple departments. She’s not afraid to say, ‘here’s how we do it’.”

More cost-effective than alternative solutions

Alkalon has evaluated both internal hiring and alternative providers over time. However, for a company of their size, outsourcing their regulatory affairs and pharmacovigilance activities provides both economic and qualitative advantages:

“Hiring in-house would be more expensive as we would need at least two specialists, and we wouldn’t be able to attract the same level of expertise. PharmAdvice has the critical mass to do that – and we benefit from it,” Kristian explains.

A long-term collaboration based on credibility

Trust is a necessary foundation for the partnership and is a core reason for Alkalon to stay with PharmAdvice, Kristian says:

“We regularly benchmark against alternatives to stay competitive, but the quality, reliability and ease of use we get from PharmAdvice means there’s no reason to switch.”

Kristian’s advice for smaller pharma companies

Kristian Uggerhøj sees PharmAdvice’s expertise as particularly well-suited to small and mid-sized pharmaceutical companies, dietary supplement brands, or international businesses without local expertise in the region. And he ends with this piece of advice:

 If you’re not yet large enough to attract the right in-house talent, outsourcing is the most practical solution. PharmAdvice is a trustworthy and highly capable partner. We would not hesitate to recommend them to companies with a similar profile to ours.”