PROFESSIONAL BACKGROUND

27 Years of Experience

RChase Consulting LLC

President/Owner

2023–Present

Provide high-impact compliance strategy and quality-system remediation to pharmaceutical, biotech, and medical device firms. Engage with C-suite and regulatory teams to design sustainable, risk-based quality systems aligned with FDA and international standards.

- Led full-scope remediation for Class II/III device manufacturers following FDA 483 and Warning Letter findings, enabling return to compliance and product relaunch.
- Designed and implemented global inspection-readiness programs, improving audit outcomes across multi-site operations.
- Advised on multiple pre-market submission strategies (510(k), NDA, BLA, IND), ensuring regulatory alignment and efficient approval timelines.
- Provided expert testimony and strategic counsel to legal and investment firms on FDA enforcement trends and due diligence.
- Developed frameworks integrating risk management, design controls, and post-market data analytics to strengthen total product lifecycle compliance.

Lachman Consultant Services, Inc.

Vice President

2016–2023

Directed multidisciplinary teams of SMEs across pharma, biotech, and medical device sectors to deliver regulatory remediation, FDA response strategies, and quality-system design for global clients.

- Built and grew Lachman’s medical device and combination-product service line with consistent year-over-year growth.
- Orchestrated multi-site remediation projects resolving FDA Warning Letters and Consent Decrees.
- Developed integrated lifecycle management frameworks, enhancing compliance transparency and accelerating product launches.
- Delivered industry presentations and thought leadership on FDA expectations, inspectional trends, and global regulatory alignment.
- Strengthened business development and client retention through strategic partnerships and trusted advisory relationships.

U.S. Food & Drug Administration (FDA) Dir. of Investigations

1998–2016

Directed all FDA inspectional, import, and compliance programs for the Chicago District across pharmaceuticals, biologics, medical devices, and food commodities. Led 70+ investigators and supervisors; oversaw complex enforcement actions, recalls, and emergency response operations.

- Spearheaded high-profile investigations leading to national enforcement actions, injunctions, and consent decrees.
- Directed international inspections and coordinated joint operations with Interpol, DEA, and USDA.
- Established new leadership frameworks improving field performance, diversity, and productivity.
- Consistently exceeded agency performance goals and shaped national policy initiatives.
- Served as supervisory investigator and medical device specialist prior to directorship, earning multiple commendations for national impact cases.

AWARDS

Mexican Rice Response (Cross-Cutting)

Compounding Team

NATO Summit

Commissioner's Special Citation - Necrotizing Enterocolitis Group

ORA Mentoring Program Committee

Adulterated Chili Powder Seizure

Leveraging and Collaboration - ED Products Team

Adulterated Topical Antimicrobial

Outstanding Contribution to Basic Medical Device Course

Medical Device Consent Decree

Leveraging and Collaboration - Cronobacter Group

Tissue Residue Injunction

Center for Devices Special Recognition – GAMBRO

Leveraging and Collaboration - Medical Device Training Group

Outstanding Service Award - Triazine in Animal Feed

Botulinum Toxin Response

Pet Food and Animal Food Contamination Response

Commissioner's Special Citation - Liberty Shield

Commissioner's Special Citation - ORA Counterterrorism

Outstanding Service Award - Ephedrine Seizure Group.

Outstanding Service Award, United States Attorney's Office

TRAINING

United States Food and Drug Administration

Food, Drug & Cosmetic Act | Food and Drug Law | Evidence Development | Compliance Law I & II |

American Management Association