Governance

Mipsalus is committed to conducting business ethically and responsibly, and we comply with relevant laws, guidelines, and international standards in our operations.

Clinical Trials

We conduct our clinical trials in close collaboration with healthcare professionals, scientists, people with PKU, and authorities etc. All clinical trials are performed in accordance with current ethical principles and regulatory requirements, and we ensure that all participants receive full and adequate verbal and written information about the nature, purpose, possible risks and benefits of the studies.

Patient Safety

At MipSalus, our number one priority is the health and safety of patients treated with our products. Prior to all clinical studies, we conduct thorough benefit-risk analyses considering known or foreseeable risks, any undesirable effects, contraindications, and warnings.

Furthermore, our Clinical Research Organization (CRO) partner ensures that all data is collected and stored in agreement with current laws and regulations, and we rigorously control and test the different steps of the production process and adhere to good practice (GxP) requirements described in various procedures within our Quality Management System (QMS).

Data Ethics

MipSalus is committed to ensuring that all data is handled responsibly. We process data from clinical trials, and we utilize data to expand our scientific and medical understanding, to ensure patient safety, and to generate a firmer evidence base to improve our products. Data collection, handling, and storage comply with all regulatory guidelines, and upon conclusion of a study, all samples are destroyed. In case there is a need to store samples beyond the initial agreed duration, further approval will be sought.

Animal Welfare

We depend on animal studies to examine the efficacy, pharmacokinetics, metabolism and possible side-effects of our drug candidates before we test them in humans. Animal welfare is central to us, and our animal studies are conducted in certified laboratories and are in line with relevant legislation. We strive to avoid unnecessary repetitions of animal studies and only use oral gavage when it is needed to ensure the scientific quality of a study.

Local Subcontractors 

To the largest extent possible, we collaborate with and buy products for our production from local and Danish subcontractors. We do this for multiple reasons: to limit and to simplify the monitoring of our scope 3 emissions, to enhance supply chain security, and to help retain and promote employment and knowhow in Denmark.