Regulatory support and authorities dialogue
UCR provides regulatory support for clinical studies, including regulatory applications and dialogue with authorities.
We guide you through relevant regulations and processes and provide practical support to ensure efficient and compliant study submissions and conduct.
How we can support you
Applications
Preparation and review of application documents and support throughout the submission process to the Swedish Medical Products Agency and the Swedish Ethical Review Authority.
Documentation and regulations
Guidance on requirements under Good Clinical Practice (ICH‑GCP), ISO 14155 and other applicable regulations, including the Clinical Trials Regulation (CTR), the Medical Device Regulation (MDR) and the General Data Protection Regulation (GDPR).
Dialogue with authorities
Support in communication with authorities, including responses to requests and follow‑up during the review process.
Registrering av studier och prövningar
Registration of clinical trials in systems such as CTIS, as well as support for ethics applications and study registration in ClinicalTrials.gov and EudraCT.
Ongoing regulatory support
Handling amendments, safety reporting and follow‑up throughout the study lifecycle.
Contact us
Need support with regulatory requirements or study applications? Get in touch to learn more.