Supply chain support, strategic and operational.
Supply chain in biotech is rarely just one thing. Some engagements need a leader to set direction. Others need experienced hands to run the work. We do both, and help you figure out the right mix.
Every engagement starts with a conversation, usually an hour, focused on what you're trying to accomplish and where the supply chain gaps are. From there we agree on scope, structure, and time commitment before anything formal begins.
Senior supply chain leadership on a part-time basis, typically two to three days a week, scaling up during critical periods. A consistent senior partner embedded in your team. Most engagements run three to twelve months.
Full-time leadership for a defined period, covering a departure, a leave, or a transition while you hire. The work keeps moving and the organization keeps its momentum.
Focused work on a specific challenge: a supply network assessment, a launch readiness review, a CMO qualification, an S&OP design. Defined scope, deliverables, and timeline.
Execution-level work done with you, not just advised on. Planning, supplier management, logistics coordination, clinical supply, and day-to-day operations, handled directly. For larger efforts we scale through a network of experienced professionals working to the same standard.
Building and maturing the function
Early-stage companies reach a point where supply chain needs to become a real function, not a set of tasks spread across other roles. We build it properly: the right processes, systems, and supplier relationships, on a foundation that won't need rebuilding when you scale. This applies equally to teams that already have a function but need to mature it.
Includes defining roles and ownership, planning processes and cadence, supplier governance, inventory practices, and the reporting tools the team needs to operate.
Clinical supply chain management
Hands-on management of clinical supply, run directly. Demand and supply planning, IMP logistics, CMO coordination, labeling, and distribution to site, so trials stay supplied and on schedule. A steady operational presence or extra capacity alongside your existing team.
Includes clinical demand planning, IMP and comparator sourcing, depot and distribution management, labeling and packaging coordination, and CMO scheduling.
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 out, this is the right time to start.
Includes commercial manufacturing campaign planning, packaging and labeling, serialization and DSCSA, cold chain validation, state licensing, and launch timeline coordination.
Supplier qualification and CMO management
Your supply chain is only as strong as your external partners. We select, qualify, contract, and manage CMOs, 3PLs, and critical suppliers across drug substance, drug product, and packaging and labeling, building the relationships and governance that keep complex networks working under pressure.
Includes CMO selection and evaluation, site audits, tech transfer management, quality agreements, deviation and CAPA oversight, QBR facilitation, and capacity planning.
Process improvement and evolution
Processes that have outgrown how they were first set up. We assess what's working, redesign what isn't, and build the ways of working that make the function faster and more reliable as you scale, tightening the handoffs between teams along the way.
Includes S&OP refinement, workflow redesign, operational excellence practices, system and tool improvements, and cross-functional handoff design.
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, design organizational structures that match operational complexity, and lead the S&OP processes that keep supply aligned with commercial and regulatory goals. This is work we do as embedded leaders, accountable for the outcome, and able to translate strategy into a clear narrative for a board room or an investor update.
Includes global network assessment, build vs. buy analysis, dual-sourcing strategy, org design and hiring plans, S&OP design, and board-level reporting.
Risk and supply chain resilience
Single-source suppliers, geography-concentrated networks, and planning that assumes everything goes to plan: 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.
Includes 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 inside a regulatory framework most industries never encounter. We bring direct experience with 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.
Includes supply chain contributions to BLA and NDA filings, pre-approval inspection readiness, supplier qualification documentation, GMP audit preparation, and regulatory change management.
Not sure which kind of support fits?
Most conversations start with a situation, not a service. Tell us where you are and we'll figure out the right structure together.