Obsidian Excellence Group is a strategic quality and regulatory advisory practice for FDA-regulated life science organizations. We build quality systems that hold under pressure  — not just on paper.                                                                   
                                                                                              
Our work is grounded in One Quality™: a connected lifecycle governance framework built on the principle that quality is not a series of disconnected checkpoints. It is a continuous flow of accountability from molecule to market.
                                                                                              
We support pharma, biopharma, biologics, small molecule, CRO, 503B compounding pharmacy, medicinal cannabis, botanical, and government-regulated life science organizations — from early clinical development through commercialization, remediation, and inspection response. 
                                                            
30+ years of GxP quality leadership. 50+ audits and inspections across FDA, EMA, and PMDA-regulated environments. Executive-level judgment, scientific fluency, Lean Six Sigma process discipline, and full accountability for outcomes.                                   
                                                            
Core services:                                                                              
Quality Leadership & Execution Support · QMS Design, Remediation & Optimization · Inspection Readiness & Regulatory Response · AI Governance & Digital Quality Systems · Foundation Assessment · CMO Qualification Audit                      
                                                                                              
If your quality architecture has seams where it should have flow — that is where the work begins.                                                                  

Obsidian Excellence Group

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Obsidian Excellence Group

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