Christopher (Chris) Middendorf

Christopher (Chris) Middendorf

Senior Director Global Regulatory

Washington, D.C.

+1 202 804 7721

[email protected]

Languages

English

Christopher (Chris) Middendorf

Overview
Experience
Credentials
Insights and events

Chris advises pharmaceutical and biotechnology companies on complex FDA regulatory and compliance matters, with a particular focus on GMP enforcement, inspection readiness, and high‑stakes remediation. Clients turn to him when technical compliance failures place product supply, regulatory standing, or corporate reputation at risk.

Chris brings more than two decades of experience at the U.S. Food and Drug Administration, where he served as both a Drug Specialist Investigator and a Senior Compliance Policy Advisor in the Center for Drug Evaluation and Research (CDER), Office of Compliance. During his FDA tenure, he conducted and supported inspections, evaluated complex GMP failures, and contributed to the development and interpretation of compliance policy, giving him deep insight into how the Agency assesses manufacturing systems, quality culture, and remediation effectiveness.

Before rejoining Hogan Lovells, Chris served as Vice President of Strategic GMP Compliance at Parexel. In that role, he led high-risk global remediation programs, enterprise quality system transformations, and inspection readiness initiatives for multinational pharmaceutical manufacturers. His experience includes aseptic processing remediation, data integrity investigations, and executive‑level FDA engagement support.

Chris regularly supports clients responding to FDA Form 483 observations, Warning Letters, import alerts, and consent decree‑level risk. His work emphasizes identifying systemic root causes and implementing sustainable, enterprise‑wide quality management frameworks aligned with FDA expectations for Quality Management Maturity, with the goal of restoring regulatory confidence and strengthening long‑term compliance.

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.