Information

PharmaRelations, Protecting you from the risk of Non-Compliance

Managing risk in the life sciences sector is complex due to evolving regulations, the need for consistent oversight across research, manufacturing, and supply chains as
well as the introduction of new technologies and therapies.

Companies must balance innovation with compliance, ensure data integrity, and maintain oversight of partners and suppliers, all while fostering a culture that
encourages proactive risk identification and mitigation.

Our approach focuses on anticipating risks, implementing robust controls, and continuously monitoring processes to safeguard patient safety, product quality,
and regulatory compliance.

Want to read more about what we can help you with? Click here 

Our Expertise

What happens if we don’t validate, which risks are we really taking?

Since July 2025, data governance has become even more central in clinical operations and clinical trials. This shift is driven by the updated ICH-GCP E6(R3) guidelines, which now place stronger and more explicit expectations on sponsors and CRO:s, particularly regarding the validation and oversight of computerized systems used in GxP-regulated activities.

These changes raise important questions about compliance, documentation, and risk management.
Are your processes ready to meet the new standards?

Katarina Grip
Senior Consultant QA IT
+46 70 641 16 56
Email me

👉 Explore what these updates mean for your organization and how PharmaRelations can help you stay compliant. Learn more on our website.

Our Services

Emma Axelsson
Head of Medical Device
+46 70 165 22 70
Email me

Building Confidence in Compliance, with PharmaRelations

In a fast-changing regulatory world, compliance isn’t just about meeting requirements, it’s about staying ahead. 

At PharmaRelations, we help Medical Device and IVD companies navigate MDR, IVDR, and quality challenges with confidence.

From QMS optimization and technical documentation to audits and PRRC support, our experts ensure structure, compliance, and business continuity.

Our experienced specialists work side-by-side with your team as consultants in your projects or in long-term partnerships to strengthen compliance and secure business continuity.

Let’s turn compliance into your competitive advantage. 

👉 Want to learn more? Contact Emma Axelsson.

Click "Read more" and learn more about how we can support your QA/RA success. 

Events and Webinars

Networking event Sweden | Sponsor Oversight in Clinical Trials
Date 12 Nov

We are excited to invite clinical trial professionals to a networking event to connect and discuss best practices, challenges and adaptive strategies in documentation of sponsor oversight.

Register to event 

 

Morning seminar in Denmark | What Do You Do
if a Crisis Hits?

Date 19 Nov

This morning, you will receive concrete guidance on what you,
as a leader, and your company can do to navigate these new conditions and how to be better prepared if a crisis should occur.

Register to event

 

Morning seminar in Norway | How to build resilience for yourself and those around you?
Date 19 Nov

In this inspiring talk, you will meet Kenneth Brendjord, an experienced and award-winning leader, who shares honest experiences about stress, burnout - and the path to balance.

Register to event

 

Webinar | Omnichannel meets Compliance
Date 27 Nov

Join us as we reframe omnichannel initiatives to align with regulations and accelerate execution.​

Register to event

 

Event | How does AI affect us – and what do we do about it?
Date 2 Dec

With a focus on AI and robotics in Life Science, the lecture explores how technology is shaping the future of healthcare, research, and the workplace.

Register to event

 

Morning seminar in Finland | Omnichannel meets Compliance
Date 3 Dec

Come and discuss current pharmacovigilance issues. What do
you think about the role of a pharmacovigilance expert now
and in the future?

Register to event

 

We want to be the Best Place to Work in Nordic Life Science.
Join the PharmaRelations family — see our open positions at PharmaRelations.com

 Webinars, events, and trainings – learn more & register here!

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