Building the supply chain function
Early-stage companies reach a point where supply chain needs to become a real function — not a set of tasks distributed across other roles. We build it properly from the start: the right processes, the right systems, the right supplier relationships, and a foundation that won't need to be rebuilt when you scale. This applies equally to organizations that already have a supply chain function but need to mature it — adding structure, improving processes, establishing S&OP, and building the organizational capability that allows the function to grow with the business.
This typically includes defining roles and responsibilities, establishing planning processes and cadence, setting up supplier governance, implementing inventory management practices, and building the reporting and visibility tools the team needs to operate.
Commercial launch readiness
Commercial launch is one of the most complex, highest-stakes coordination challenges in biotech. We've led this work — BLA approval timelines, commercial manufacturing readiness, distribution network setup, and the cross-functional alignment that ensures supply availability on day one. If you're twelve to eighteen months from launch, this is the right time to start.
Specific workstreams include commercial manufacturing campaign planning, packaging and labeling development, serialization and DSCSA compliance, shipping lane qualification, cold chain validation, state licensing, distribution center readiness, and cross-functional launch timeline coordination.
Supplier qualification and CMO management
Your supply chain is only as strong as your external partners. We help you select, qualify, contract, and manage CMOs, 3PLs, and critical suppliers across drug substance, drug product, and packaging and labeling — building the relationships and governance structures that make complex networks work. This includes site qualification, tech transfers, manufacturing agreements, and the day-to-day operational oversight that keeps supply moving and relationships healthy.
Day-to-day work includes CMO selection and evaluation, site audits, tech transfer management, quality agreement negotiation, deviation and CAPA oversight, batch disposition coordination, QBR facilitation, and capacity planning across your manufacturing network.
Supply chain strategy and organizational design
As companies grow, supply chain strategy needs to evolve. We define global supply network strategy, assess build vs. buy decisions, design organizational structures that match operational complexity, and lead the S&OP processes that keep supply aligned with commercial and regulatory objectives. This is work we do as embedded leaders — not outside advisors. Sitting in the room, making the decisions, accountable for the outcomes, and able to translate supply chain strategy into the kind of clear narrative that works in a board room or an investor update.
This covers global supply network assessment, make vs. buy analysis, dual-sourcing strategy, organizational design and hiring plans, S&OP process design and facilitation, and board-level supply chain reporting.
Risk and supply chain resilience
Single-source suppliers, geography-concentrated networks, planning processes that assume everything will go as planned — these risks often go unaddressed until they become crises. We identify concentration risk, develop business continuity plans, and build the scenario planning and inventory strategies that keep supply moving when something doesn't.
Including single-source risk assessment, business continuity planning, safety stock strategy, scenario modeling, and supplier diversification roadmaps.
FDA and GMP compliance readiness
Supply chain in biotech operates within a regulatory framework most industries never encounter. We bring direct experience navigating FDA requirements, GMP compliance, and the supply chain dimensions of BLA filings — documentation, supplier qualification requirements, and the operational practices that support a successful inspection.
Covering supply chain contributions to BLA and NDA filings, pre-approval inspection readiness, supplier qualification documentation, GMP audit preparation, and regulatory change management.