Our Story
15 years inside the rooms where these decisions are made.
More than 15 years driving regulatory and quality strategy across the full product lifecycle for global life sciences organizations: FDA submissions, health authority inspections, CAPA programs, design control governance. Regulatory, quality, and engineering are not treated as separate functions here. They operate as one discipline.
It began in process and product engineering, hands-on technical work that still shapes how strategy is developed today, in the language the teams designing and manufacturing the product actually use. Root-cause thinking has carried through since: investigations that trace a problem to its actual source rather than stopping at the symptom.
The range spans leading regulatory strategy for Class II and III device portfolios across global markets, securing clearances and approvals for new product releases, and auditing experience across quality, compliance, and regulatory affairs, along with separate disciplines built on that same root-cause approach: nonconformance and complaint investigation, recall execution, and supply chain and distribution deviation management.
Treating regulatory, quality, and engineering as one discipline, rather than three separate handoffs, is what separates a defensible submission from one that draws a Form 483. Backed by ISO 13485:2016 Lead Auditor and ISO 19011:2018 auditor certifications, applied across internal audits, mock inspections, and health authority readiness work.
That standard carries into Vellum Strategy Group: senior-level expertise applied to your program from the first conversation.