Soterius provides services related to global safety, medical affairs, regulatory and technology enabled solutions to clients globally.
All of our internal processes are designed with a unique structure that includes detailed descriptions of the responsibilities of all personnel involved in the process, so that ownership resides with the person performing each step of the process, and thus ensuring quality.
Soterius can also create client-specific procedures that supplement central processes so that the team has a one-stop solution for executing a single project-related deliverable, rather than having to refer to multiple documents.
Each domain (e.g., case processing, literature review,
aggregate report preparation, signal management,
etc.) is subject to periodic internal quality audits
and the process-specific SOPs ensure that
documentation and archival are always audit-ready.
Soterius’ quality policy provides guidance for
the establishment and maintenance of quality
assured GxP systems within the organization. This
quality policy is implemented through the Quality
Management System (QMS). The specific processes
of individual systems and their interactions are
described in the procedural documents of the
individual systems and are as per the applicable
regulations, guidance and industry best practices.
The quality policy has been framed with an objective
to provide an understanding of Soterius’ QMS. The
quality policy provides an overview of the approach
and commitment of the management towards the
quality standards.
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