Clinical Inspection Facilitation - FormaliS

FormaliS provides you support when an inspection from authorities is anticipated, announced and/or conducted.

Activity:

Preparation and training of teams to get ready for inspection.
Facilitation of inspections by being present while the inspections are carried out.

Scope:

Investigational sites
Contract Research Organizations
Service providers
Sponsors

Standards:

ICH GCP
FDA Requirements
EU Directives and Guidelines
Local Clinical Trial Regulations