We are Soterius – a strong team of experienced professionals from the pharma industry. We design customized, innovative, and cost-efficient processes for clinical safety, pharmacovigilance, and medical affairs. Our deep industry knowledge and up to date insights let us combine agile, people powered intelligence with big data in pioneering customer centric solutions.


We have a truly global presence capable of handling complete pharmacovigilance support and medical affairs across multiple geographies.

Core expertise in drug safety, medical affairs and regulatory services.

150+ people worldwide providing regulatory, scientific and medical support.

Delivery centers and local experts in multiple geographies, including North America, Europe and Asia.

Supporting the top 5 global pharma companies for safety and medical Affairs.

250+ products supported and over 1,000 EU regulatory submissions made.

Engagement platforms for HCPs and various medical teams.

60+ countries with QPPV and local safety representatives.

50+ regulatory Inspections supported, including FDA, MHRA, MEB, BfArM and HPRA.

Managing and processing data across the world - working with patients, clinical sites, HCPs and regulators.

Our Clients

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