Regulatory & Compliance Support
FDA, CDC, and HHS regulatory affairs, policy compliance, and audits to ensure adherence to federal requirements.
Overview
We help federal sponsors and contractors navigate the regulatory landscape with confidence. From 21 CFR Part 11 readiness to HIPAA and FISMA controls, our compliance specialists translate policy into operating procedures, evidence packages, and audit-defensible artifacts.
Capabilities
FDA Regulatory Affairs
Submissions support, GxP advisory, and 21 CFR Part 11 electronic-records readiness.
HHS / CDC Policy Compliance
Program-level policy interpretation, SOP development, and corrective-action plans.
Privacy & Security
HIPAA, FISMA, and NIST 800-53 control mapping, assessment, and remediation.
Audit Preparation
OIG, GAO, and internal audit readiness with documentation reviews and mock audits.
Quality Management Systems
QMS design and ISO-aligned process documentation for regulated programs.
Training & Attestation
Role-based compliance training with tracked completion and attestation.
Our approach
- 01
Diagnose
Map applicable regulations to current controls and identify gaps.
- 02
Remediate
Close findings with prioritized, risk-based corrective actions.
- 03
Operationalize
Embed controls into SOPs, training, and monitoring.
- 04
Sustain
Continuous monitoring and periodic mock audits to stay inspection-ready.
Outcomes
- Zero material findings in federal audits and inspections
- Faster regulatory approvals through complete, well-evidenced submissions
- Lower compliance risk via embedded controls and recurring monitoring
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