I focus on what most consultants don't touch.
The physical materials, the supplier relationships, the CMC documentation that connects design to manufacturing. The stuff that seems straightforward until it isn't.
Everything I do.
My core is materials and consumable qualification, but the work extends across CMC, supplier management, and quality systems.
Consumable qualification
CoreEnd-to-end qualification of single-use bags, tubing, connectors, and assemblies. Materials selection, biocompatibility, sterilization validation, and full documentation from protocol through report.
Full details →Supplier qualification
CoreQualifying contract manufacturers as GMP-ready suppliers. Risk assessments, quality agreements, component specifications, incoming inspection, audit support, and ongoing monitoring.
Full details →CMC & regulatory writing
CMC authoring for NDA, ANDA, BLA, and IND submissions. Process descriptions, in-process controls, manufacturing flow narratives, and Module 3 sections. I've done this through a successful FDA approval.
Full details →E&L testing strategy
Risk-based extractables and leachables study design, protocol development, and CRO coordination for single-use components per USP <665>, ISO 10993-18, and BPOG guidance.
Full details →GMP readiness assessments
Gap assessments for your manufacturing supply chain. Documentation completeness, supplier qualification status, traceability, and regulatory filing readiness. Prioritized action plan included.
Full details →Additional capabilities
Process validation support (IQ/OQ/PQ), tech transfer documentation, formulation development, scale-up, stability programs, design transfer, CAPA/deviation management, DHF gap analysis, quality system assessments, and QMSR transition support. If it involves materials, manufacturing, or quality in a regulated environment, I've probably done it.
Flexible engagement models.
Every program is different. I scale involvement to match.
Advisory
On-demand access for technical questions, document reviews, strategy calls. No minimum. Useful when you need a sounding board, not a project.
Project-based
Defined deliverables with clear timelines. Gap analyses, qualification programs, CMC sections, documentation packages. You know the cost before we start.
Fractional / embedded
Ongoing part-time support embedded in your team. Ideal for programs that need consistent materials, CMC, or quality expertise over months.