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Leadership in Global Regulatory Compliance

Former FDA Director. 28+ Years of Regulated Industry Experience.

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Former FDA Director

Direct oversight of national enforcement and federal investigations from a central authority.

Global Expert

Elite guidance for multi-national organizations navigating intricate international quality mandates.

28+ Years Experience

Unrivaled seniority in pharma, device, and biotech remediation for high-stakes stakeholders.

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Former FDA Investigations Chief

Bridging Federal Oversight and Global Strategy

Ricki A. Chase is a former FDA Director of Investigations and elite compliance strategist with 28+ years of leadership across pharma, device, biotech, and combo product sectors.

She transforms complex regulatory hurdles into sustainable business advantages—architecting risk-based quality systems that meet the highest FDA and international standards.

Ricki leverages her background in federal enforcement to provide C-suite leaders with the decisive counsel needed for high-impact remediation and inspection success.

PHARMA

DEVICE

COMBO

BIOTECH

BIMO

Executive Regulatory Strategy

Translating FDA complexity into decisive competitive advantages for industry leaders.

Inspection Readiness

Expert audit preparation for FDA and Notified Bodies, featuring mock inspections and investigator coaching.

Governance & Pathways

Strategic guidance for PMA, 510k, NDA, and ANDA pathways backed by elite technical submission design.

Enforcement Response

Crisis management and technical defense for 483s and Warning Letters to restore trust with federal regulators.

Risk Architecture

Deploying ISO 14971 frameworks to identify and mitigate risks throughout the entire product lifecycle.

Quality System Design

Engineering scalable quality systems aligned with 21 CFR 820, ISO 13485, and modern global requirements.

Remediation Programs

Managing sustainable remediation for systemic CAPA, data integrity, and laboratory compliance failures.

Secure Your Trusted Advisor

Expert strategic counsel for health science leaders. Request a confidential consultation to align your global quality systems with current FDA enforcement expectations today.

rchaseconsulting@outlook.com

773.558.2044

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