Compliance

Regulatory Affairs Support

We provide comprehensive regulatory leadership across the full study lifecycle from start-up through closeout. Submissions, amendments, approvals, and ongoing maintenance are structured to reduce delays, rework, and regulatory risk while remaining fully aligned with GCP standards and sponsor expectations.

Audit Preparation   Sponsor & FDA

We prepare sites for sponsor audits, CRO assessments, and FDA inspections through proactive, structured preparation. Documentation, SOP adherence, data traceability, and staff readiness are aligned well in advance eliminating last-minute scrambling and reducing exposure.

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Leadership and staff are coached to respond clearly, confidently, and professionally during audits.

Internal Audits & CAPA Development

We conduct structured internal audits to identify gaps before sponsors or regulators do. Findings are categorized by risk, impact, and urgency, with clear corrective and preventive action (CAPA) plans designed to strengthen long-term compliance not just fix symptoms.

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This creates control, clarity, and defensible systems.

Data Entry & Quality Control (QC)

We strengthen source documentation, eCRF completion, and internal QC frameworks to ensure data accuracy, consistency, and inspection readiness. By implementing realistic quality checkpoints and documentation standards, we reduce queries, deviations, and downstream corrections resulting in cleaner data and stronger sponsor confidence.