XGene Consulting

Regulatory. CMC. Quality.
Built for Defensible Decisions.

XGene Consulting provides strategic life sciences expertise for complex regulatory, CMC, quality, compliance, inspection-readiness, remediation, and AI-enabled CMC transformation.

Our new digital experience is being prepared for launch. XGene remains fully operational and available for consulting engagements.

FDA Regulatory & CMC
FDA 483 & Warning Letter Remediation
Quality Systems & Data Integrity
Inspection Readiness & Compliance
AI-Enabled CMCFDA PQ/CMC KASA & EMA SPOR