Our consultants
The people who do the work
xFDA is a team of former FDA investigators, compliance officers and senior industry specialists. Engagements are staffed individually — matched to the product, the process, the regulation and the problem in front of you.
Former FDA
Former FDA investigators, compliance officers and specialists
Between them they conducted pre-approval, cGMP, BIMO and device inspections, ran an investigations branch, prosecuted FDA cases and served on the International Inspection Cadre.
Dusty Snoeberg-Renwick
President & Founder — Former FDA Investigator
Former FDA pharmaceutical and medical device investigator who founded the firm in 2004 to build quality systems people can actually follow.
30+ years FDA and industry
Lisa Hornback
Former FDA — Quality Systems Specialist
Regarded at FDA as an expert in both medical device and pharmaceutical quality systems; guides firms out of Warning Letters and Consent Decrees.
30+ years FDA and industry
Timothy Couzins
Retired FDA Investigator & Compliance Officer
Known for resolving FD-483, Warning Letter and Consent Decree matters by interacting directly with the Agency on a firm's behalf.
30+ years FDA and industry
Steve Yost
Former FDA Investigator — Medical Devices
Class III device specialist covering regulatory strategy through pre- and post-market requirements, PMA/510(k) technical writing and ISO 13485.
Former FDA plus industry experience
Jennifer Menendez
Former FDA Investigator — BIMO, GMP & GCP
Conducted inspections across all product areas during a decade at FDA and was considered an expert in BIMO, GMP and GCP audits.
18+ years combined; 10 years at FDA
John Crowe
Retired FDA Investigator & Forensic Chemist
Forensic chemist from FDA's Forensic Chemistry Center; lead chemist on melamine in pet food, over-sulfated heparin and counterfeit drug identification.
33+ years FDA and industry
Marianne Allen
Former FDA Investigator & Deputy Director, Investigations Branch
Spent 25+ years inspecting pharmaceutical, biologics, bioresearch, device and food manufacturers, and served as Deputy Director of an Investigations Branch.
25+ years inspecting FDA-regulated manufacturers
Christopher Smith, CQE, RAC
Quality Assurance & Regulatory Affairs Specialist
Has successfully submitted and obtained FDA approval for NDAs, ANDAs, INDs, IMPDs, CTDs, MAs, DMFs, amendments and supplements.
30+ years FDA and industry
Terri Dodds
Former FDA Pharmaceutical Drug Expert
Sterile product and environmental monitoring specialist who evaluates technology transfers, scale-ups and validation plans.
16 years FDA; 7+ years consulting
Joseph Mastronardy, Ph.D.
Former FDA — Generic Drug Division
Guides regulatory submissions and QC method validation; served in the Generic Drug Division while at FDA.
25+ years FDA and industry
Finn Alexander Slizza
Former FDA Investigator — International Inspection Cadre
Medical device (QMSR) and biotech specialist who served on FDA's International Inspection Cadre.
20+ years FDA and industry
Nancy Singer, J.D., LL.M.
Former FDA Prosecutor & Regulatory Educator
Created Dangerous Documents — Avoiding Land Mines in Your FDA Records and Emails, presented at 75 drug and device companies and the FDA staff college.
20+ years training FDA and industry officials
Industry experts
Senior industry specialists
Quality, operations, validation, computer systems and clinical professionals who have owned these systems inside operating companies.
Shane Snoeberger, MBA, ASQ CQE
Vice President & Business Management Services Director
Quality and operations leader, certified quality engineer and Lean Six Sigma Black Belt with deep DEA registration expertise.
20+ years in FDA- and DEA-regulated industry
Deena Venezia, MBA
Computer System Validation & Compliance Specialist
Computer system and LIMS validation, gap assessments, and running the back room during FDA audits.
25+ years in pharmaceutical and device industry
Gregory Jean-Noel, MD, MBA
Clinical Medical Director & Quality Control Specialist
Physician who has overseen projects from product development through FDA submission and provides risk assessments on complaints and early development.
Many years of pharmaceutical industry experience
Robert Fannon, MBA
Clinical Research & GCP Specialist
All phases of pharmaceutical and device clinical trials, with mock-FDA audits across GCP, GXP and GLP and extensive international audit experience.
30+ years industry
Jaclyn Snoeberger, QA Associate II
Quality Assurance & Project Support
Complaint system remediation, change control, APRs, batch record review, product release and document control.
10 years in pharmaceutical and device industry
03 / Team assembly
Matching expertise to the engagement
Before proposing a team we want to understand the product, the process, the regulatory history and what has already been attempted.
- 01Scoping conversation to understand the situation, the timeline and the constraints.
- 02Identification of the disciplines required — often fewer than clients expect.
- 03Consultant selection based on directly relevant product and process experience.
- 04Defined deliverables, on-site and remote allocation, and a realistic schedule.
- 05Ongoing oversight by firm leadership through the life of the engagement.
Experienced professionals: work with us
We continually add former FDA professionals and senior industry specialists to the team. Submitted information is held confidentially.
Start a project
Tell us what you're working on.
Describe the product, the process or the problem. We will tell you honestly whether we are the right people to help, and who should be on the team if we are.