Navigating FDA Consulting Group

Where FDA Experience Meets Regulatory Excellence

About Me

With over 23 years of experience working for the United States Food and Drug Administration as an Investigator, Supervisory Investigator, and Compliance Officer, I bring unparalleled expertise and insight into regulatory compliance and enforcement. My deep understanding of FDA processes and expectations enables me to guide clients smoothly through audits, inspections, and import challenges.

My Services

1. Regulatory Compliance Audits (Domestic & Import)

Conduct mock FDA inspections (GMP, FSMA, etc.)
Identify gaps in quality systems and SOPs
Prepare facilities for FDA and foreign regulatory inspections

2. Import Operations & Detention Resolution

Assist with FDA import entry reviews (product codes, Prior Notice, ACE)
Resolve Import Alerts, DWPEs (Detention Without Physical Examination), and refusals
Guide firms through submission of successful Requests for Removal from Import Alert

3. 483 & Warning Letter Response Strategy

Analyze FDA Form 483 observations or Warning Letters
Draft or review response letters with CAPA plans
Help ensure compliance in follow-up inspections

4. Regulatory Strategy for Market Entry (U.S. & Foreign Firms)

Advise on U.S. FDA requirements for foreign manufacturers/exporters
Assist with FDA registration, listing, and U.S. Agent services
Help importers navigate product admissibility, labeling, and regulatory pathways

5. Training & Compliance Education

Provide in-house training for quality, regulatory, and operations teams
Topics may include: FDA inspection readiness, FDA import processes, GMP basics, FDA enforcement trends, and more
Tailored workshops for executives or frontline staff

Contact Me

Ready to navigate FDA regulations with expert guidance? Reach out today!