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About & Credentials

Senior Regulatory and Quality Strategy

Regulatory and quality leadership for medical device manufacturers facing high-stakes submissions, audits, and remediation.

Mission Story The Name How We Work

Our Mission

Standard of Work

The practice is built for high-stakes moments: a submission to the FDA under deadline, an inspection that raised more questions than it answered, a CAPA program that needs to hold up, not just close. Regulatory, quality, and engineering are treated as one discipline, which is what separates a defensible submission from one that draws scrutiny.

Vellum Strategy Group works on milestone-based projects and ongoing fractional or retainer support, within CRO partnerships, prime vendor networks, and direct manufacturer relationships. Vellum Strategy Group is not currently accepting new client engagements.

Core Values

Senior-Level Expertise

Regulatory and quality strategy grounded in hands-on engineering and industry experience.

Audit-Ready Rigor

Documentation and governance built to hold up under scrutiny, using the same standards the FDA and Notified Bodies apply in their reviews.

Cross-Functional Depth

Regulatory, quality, and engineering are addressed together, closing the gaps that surface at audit.

Our Story

Regulatory and Quality Strategy Grounded in Process Excellence

Regulatory and quality strategy across the full product lifecycle for global life sciences organizations: submissions to the FDA, health authority inspections, CAPA programs, and design control governance.

That career began in process and product engineering. The hands-on grounding still shapes the work: strategy is written in the language of the teams who design and manufacture the product. Root-cause thinking ran through it from the start, tracing a problem to its source rather than stopping at the symptom.

ISO 13485:2016 Lead Auditor, TPECS Certified ISO 19011:2018 Auditing & Team Leadership, AU, TL Certified

The Name

The Name Vellum

For centuries vellum was the surface reserved for the documents that mattered most. Many of those pages are still legible today.

It was also hard to falsify. An erasure left a trace. Scholars have recovered the original text from beneath pages that were scraped and reused.

A regulatory file is held to the same standard. The record has to endure and to show when it has been changed. Vellum is named for that standard.

Etymology

vellum

/ˈvɛləm/ · noun

A writing surface reserved for records meant to last.

  1. Old Frenchvélin
  2. Middle Englishvelym
  3. Todayvellum

How We Work

Delivery Phases

Milestone-based or fractional engagements, with rapid onboarding for urgent regulatory interventions.

§1

Discovery & Diagnostic

A confidential intake call to understand your current regulatory and quality posture, optionally paired with a diagnostic assessment to establish a baseline risk assessment before anything is scoped.

§2

Scoping & Statement of Work

Defined deliverables, timeline, and milestones agreed before work begins.

§3

Execution

Senior regulatory expertise leads strategy, documentation, and remediation: submissions drafted, audits run, CAPAs closed.

§4

Governance Handoff

Your internal teams receive the frameworks, templates, and change-control processes to sustain compliance independently.

§5

Ongoing Advisory (optional)

Interim expert leadership or on-call support through your next audit cycle, inspection, or submission.

Discuss Your Program

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