I help life sciences companies qualify materials, consumables, and suppliers for GMP manufacturing.
From cell therapy consumables to pharma formulation scale-up to medical device supplier programs - I make sure the things your process depends on are qualified, documented, and ready for inspection.
Different industries, same core challenge.
Your product has to be manufactured in a regulated environment, and the materials, consumables, and suppliers that feed your process need to be qualified. I've done this across four industries.
Cell & gene therapy
Consumable qualification, single-use systems, supplier management, and GMP readiness for CAR-T and other cell therapy manufacturing.
Learn more →Pharma CMC
Formulation development, CMC authoring, process scale-up, tech transfer, and regulatory writing for small molecule and biologic products.
Learn more →Medical devices
ISO 13485 supplier qualification, design transfer, CAPA management, QMSR transition support, and quality system assessments.
Learn more →CDMOs
Tech transfer support, manufacturing readiness, supplier audits, validation, and quality system buildout for contract manufacturers.
Learn more →Materials, consumables, suppliers, and the documentation that connects them.
Most consultants focus on process or regulatory strategy. I focus on what your process physically touches - and making sure it's qualified.
Consumable qualification
End-to-end qualification of bags, tubing, connectors, and cartridge assemblies. Materials, biocompatibility, sterilization, and documentation.
Learn more →Supplier qualification
Qualifying contract manufacturers as GMP-ready suppliers. Audits, quality agreements, specifications, and monitoring programs.
Learn more →CMC & regulatory writing
CMC authoring for NDA, ANDA, BLA, and IND submissions. Process descriptions, manufacturing narratives, and Module 3 support.
Learn more →E&L testing strategy
Extractables and leachables study design for single-use components per USP <665> and ISO 10993.
Learn more →GMP readiness
Getting your supply chain inspection-ready. Documentation, traceability, and regulatory filing support.
Learn more →Real problems I've solved. Names changed, outcomes real.
From my work across cell therapy, medical devices, and pharma development.
Took a drug product from formulation through manufacturing, validation, and FDA approval
Designed the manufacturing process, executed validation campaigns, managed stability programs, and authored the CMC sections that supported a successful FDA approval. Product launched commercially.
Built an entire consumable qualification program from scratch for a commercial CAR-T platform
Created a 9-phase qualification framework spanning material traceability, E&L studies, biocompatibility, sterilization validation, and GMP documentation. Program is the critical path for the regulatory filing.
Served as the global authority on single-use materials for a multi-site CAR-T program
Served as the global point of contact for single-use plastic materials. Led alternate supplier qualification that reduced single-source dependency on a critical raw material.
Three steps. No mystery.
I don't do multi-month discovery phases or 80-slide decks. I figure out what you need, scope the work, and deliver.
Strategy call
30 minutes. You describe the challenge, I tell you honestly whether I can help. If it's not a fit, I'll point you toward someone who can.
Scope and proposal
A clear scope with deliverables, timeline, and pricing. You know exactly what you're getting before we start.
Execution
I do the work. Regular check-ins, but no status meetings about status meetings. You hired me to deliver - so I deliver.