Our European Collaborators – Local Expertise, Central Leadership
At GBA Key2Compliance, we lead and manage all clinical studies centrally from Sweden. Through our trusted European collaborators, we ensure full local compliance and operational efficiency.
Our partners provide expert support in language, national regulatory requirements, and local monitoring – acting as an extension of our team. All collaborators are fully qualified and regularly audited by GBA Key2Compliance.
UK, Spain and Portugal
Tailored clinical development expertise – from one consultant to a fully outsourced function.
Even when you bring in one of us, you get the strength of an entire team.
UK, EU wide
We work with your team to define clinical strategies that support your business goals – including study design, endpoint selection, and evidence planning across the lifecycle.
Early-phase to post-market.
Netherlands
From planning to close-out, we help you run ISO 14155 and ISO 20916 compliant clinical studies
Adapted to your device, endpoints and market goals.
Belgium
We support the full evaluation process for medical devices and IVDs – from literature review and State of the Art to complete CERs and PERs.
Aligned with MDR, IVDR and Notified Body expectations.