Christopher (Chris) Middendorf

Christopher (Chris) Middendorf

Senior Director Global Regulatory

Washington, D.C.

+1 202 804 7721

christopher.middendorf@hoganlovells.com

Languages

English

Christopher (Chris) Middendorf

Overview
Experience
Credentials
Insights and events

Crisis Manager | Strategic Regulatory Fixer | Global GMP Authority | FDA Communication Lead

When a regulatory crisis threatens a pharmaceutical product’s lifecycle or a firm’s global reputation, clients don’t need a consultant; they need a Tier-1 compliance strategist. I serve as a strategic fixer for CEOs, General Counsel, and Heads of Quality, navigating the high-stakes environment where complex technical failures meet rigorous Agency policy.

With 21 years at the U.S. FDA—serving as both a Drug Specialist investigator and a Senior Compliance Policy Advisor at CDER’s Office of Compliance—I offer a unique dual-lens perspective. Prior to re-joining Hogan Lovells, I was Vice President of Strategic GMP Compliance at Parexel, where I led high-stakes remediations and global QMS optimizations. I’ve been on the shop floor identifying the fundamental failures that lead to regulatory enforcement actions, and I’ve been at CDER helping shape the very policies that govern them. This "battle-tested" experience allows me to translate systemic gaps into sustainable regulatory success.

I am known for delivering "The Save" for clients facing critical hurdles. Whether I am architecting a roadmap for a client facing an FDA enforcment action, navigating complex aseptic remediations, or leveraging my experience as a diplomat in China and India to stabilize an international supply chain, my goal is the same: to restore regulatory trust.

What sets my approach apart is the "Science of Compliance." I don’t just provide tactical fixes; I build frameworks that move firms beyond site-specific issues toward enterprise-wide Quality Management Maturity (QMM). By addressing systemic root causes and harmonizing quality culture across global footprints, I help firms protect their "License to Operate" and ensure that life-saving therapies reach the patients who need them.

Representative experience

The "First Call" Strategist: Serves as a strategic fixer for CEOs and GCs when regulatory challenges or technical failures lead to FDA enforcement action or threaten a firm’s reputation.

Technical Remediation: Architects "Science of Compliance" frameworks to address root causes, ensuring remediations withstand the scrutiny of FDA verification inspections.

FDA Communication Strategy: Guides firms through Agency dialogue to resolve Warning Letters and Form 483s while restoring regulatory trust and protecting the license to operate.

Aseptic & Sterile Operations: Provides technical solutions for contamination control (While at FDA, served on the CDER team responsible for the review and revision of EU Annex 1).

Enterprise QMM Frameworks: Applies Quality Management Maturity (QMM) frameworks to assess and harmonize quality culture across global enterprises and corporate footprints.

Simulated FDA Inspections: Performs audits mirroring the technical rigor of a field investigator and the policy-based scrutiny of an FDA Center reviewer to ensure launch readiness.

Data Integrity Investigations: Leads forensic reviews across the GxP spectrum (QC, GCP, GLP) to resolve systemic gaps and prevent potential FDA enforcement action.

Aseptic Remediation: Led remediation for a client facing consecutive FDA withholds; implemented programs that resulted in successful re-inspection and product approval.*

Return to Operations (RTO) Leadership: Architected RTO roadmaps for firms under FDA enforcement action; served as external co-chair for RTO Committees to ensure sustainable compliance.

M&A Technical Due Diligence: Technical lead for BLA-stage acquisitions valued at over US$300m, conducting CMC reviews to quantify regulatory risk and liabilities.

International Supply Chain: Former FDA Diplomat in China and India; provides insight into foreign inspectional trends and CDMO oversight to mitigate the risk of FDA enforcement action.

Enforcement Leadership: Leveraged experience as an FDA investigator on landmark inspections (including Ben Venue consent decree), to help clients navigate rigorous regulatory environments.*

*Matter handled prior to joining Hogan Lovells.