Compliance & Standards

Clinical Research

GCP frameworks, inspection readiness, TMF quality, and sponsor/vendor oversight for clinical programs.

Regulatory landscape

Standards and frameworks in this category

Each topic links to an existing Viltis service page describing implementation, assessment, and remediation support.

Quality-by-design, risk proportionate approaches, and GCP readiness.

Sponsor and site preparation for FDA, EMA, and other inspections.

TMF completeness, quality review, and inspection-ready organization.

Vendor qualification, oversight plans, and performance management.

CQA programs supporting GxP trial quality across product types.

Related engagement

Phase III biologics analytical development support with LCMS expertise and new CRO relationships.

Share your current controls, upcoming audits, or remediation priorities.