Est. 2004
FDA-Experienced Regulatory, Quality & Compliance Consulting
Former FDA experience.Practical industry solutions.
Compliance should be rigorous. It doesn't need to be cumbersome — a quality system only works if the people doing the work can actually follow it.
What we do
All expertise →- Regulatory & SubmissionsManufacturing, CMC and quality content for 510(k), De Novo, PMA, IDE, IND, NDA, ANDA and BLA submissions.
- Quality Systems & cGMPDesign, assessment, optimization and remediation of pharmaceutical and regulated quality systems.
- Validation & QualificationProcess validation, cleaning validation, equipment qualification, IQ/OQ/PQ and lifecycle validation support.
- Laboratory Compliance & Data IntegrityLaboratory quality systems, analytical operations, documentation, data integrity and GLP/GMP compliance.
- Pharmaceutical Development & ManufacturingQuality and compliance support throughout development, scale-up, technology transfer and commercial manufacturing.
- CAPA, Deviations & RemediationRoot-cause investigations, CAPA systems, deviation management and sustainable corrective actions.
Specialty practices
Where our depth is greatest
- Flagship practiceMedical DevicesQuality systems & QMSR · Design controls & design history files · CAPA, complaints & remediation · Manufacturing, supplier & validation quality
- Commercial practiceDietary SupplementsPart 111 GMP & quality systems · Component identity & supplier qualification · Laboratory controls & testing · CAPA, remediation & training
- Laboratory practiceLaboratoriesLaboratory GMP & quality systems · Data integrity · Investigations: OOS, OOT & CAPA · Methods, transfer & stability
- Clinical quality practiceClinical ResearchClinical quality systems & GCP · Sponsor oversight & vendor quality · Clinical audits & data integrity
Expert Answers
All answers →- Quality SystemsWhat does a former FDA investigator look for in a quality system?Whether the system described on paper is the system the organization actually runs. An investigator follows a small number of records end to end — a complaint, a deviation, a batch, a change — and checks that each handoff happened when the procedure said it would, by someone qualified to make the decision.
- Medical DevicesWhat does QMSR mean for medical device manufacturers?FDA's Quality Management System Regulation replaces the Quality System Regulation in 21 CFR Part 820 by incorporating ISO 13485 by reference, effective February 2, 2026. For most manufacturers already certified to ISO 13485 the change is one of terminology, documentation mapping and record expectations rather than a wholesale system rebuild.
- Medical DevicesWhat are the most common design control weaknesses in medical devices?Design inputs written as marketing statements rather than verifiable requirements, verification that does not trace to a specific input, and design changes made after transfer without returning to the design file. Nearly every design control observation traces back to one of those three.
Have a question of your own? Ask our experts.
Our consultants
The people are the firm.
We know what FDA expects because many of us spent years evaluating these systems from inside the Agency. Then we learned what it takes to make them work inside industry.
- Shane Snoeberger, MBA, ASQ CQEVice President & Business Management Services Director
- Lisa HornbackFormer FDA — Quality Systems Specialist
- Timothy CouzinsRetired FDA Investigator & Compliance Officer
- Steve YostFormer FDA Investigator — Medical Devices
- Jennifer MenendezFormer FDA Investigator — BIMO, GMP & GCP
Regulated products / real-world expertise
Whatever you make, it has to hold up.
Inside the work
Validation / Pharmaceutical Manufacturing
A validation program had grown into 47 SOPs nobody could execute consistently.
We mapped every requirement to a single validation master plan, collapsed the procedure set, rewrote protocol templates against actual equipment and trained the people who run them.
Complexity is not rigor. A program the floor cannot follow will generate the very findings it was written to prevent.
Technology Transfer / Scale-Up
An organization needed to move from development to commercial GMP manufacturing.
We built the transfer package — process description, control strategy, comparability and acceptance criteria — qualified the receiving site and sequenced validation against the supply plan.
Transfer failures are almost always knowledge failures. What is not written down does not move between sites.
Tell us what the problem actually is.
A short scoping conversation is usually enough to tell you whether this is a two-week assessment or a governed program — and who should be in the room.