SanaClis is honored and grateful to have been awarded the Félix Business Award in the main...
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Reach out to our team of Pharmacoviligance experts to discuss your project needs or more obtain update guidance.
Patient safety and subsequent reporting are at the forefront of our Pharmacovigilance activities
SanaClis operates exclusively compliant PV systems, aligned with the European Medicine Agency Guidelines on Good Clinical and Good PV Practices and 21 CFR part 11 regulatory requirements.
Our seasoned team of experts have a deep understanding of all facets in the provision of complex PV-related medicinal product life cycle management, commencing with clinical trial phase I-IV and continuing to post marketing surveillance.
We provide custom-tailored trainings, drug and device vigilance relevant project management, safety reporting intelligence covering multiple countries of the world and consultancy services
SanaClis Pharmacovigilance department additionally provides end-to-end PV related support for Medical device studies. Medical Device Vigilance & Reporting is performed in line with the requirements of the Regulation (EU) 2017/745 – Medical Device Regulation (MDR)