Your integrated partner for GMP material introduction.
Single-use technology, raw materials and MRO soft parts: designed, selected, enrolled, qualified and released, as a managed service across your sites.
One accountable program
Single-use and raw material design, selection, ERP enrollment, qualification and specification usually sit with different people, on different timelines, in different systems. When one moves, the others do not follow.
We execute the full program, working in your systems, under your SOPs. Qualification is written to applicable FDA and EMA guidance and industry best practices. You get qualified, ERP-enrolled materials with approved specifications your procurement team can buy against.
The Lighthouse Framework
One auditable lifecycle
Design, introduce, qualify, release
Material Selection & Design
Translate process requirements into audit-ready assemblies, without costly redesign cycles.
Get to audit-ready faster.
Supply Chain & ERP
Convert your GMP materials from a sourcing variable into a controlled, predictable asset.
Gain control of your supply chain.
Qualification & Compliance
Build a qualification program that survives regulatory scrutiny and scales with your portfolio.
Build a scalable qualification program.
GMP Release & Sustain
Keep GMP workflows on track and inspection-ready, from first batch to ongoing compliance.
Stay inspection-ready from day one.
Know where your program stands before you scope the work
Our GMP Maturity Diagnostic tool is a free, online eight-question self-assessment that takes under three minutes. It gives you a clear read on where your program stands and what to prioritize first, so you know what's worth raising with your team.
Start the diagnostic8 questions · under 3 minutes · top 3 priorities
Results our clients have measured
Up to 90%
reduction in E&L qualification timelines
Zero
downtime on a supplier change notification, assessed against your full library on receipt
70% fewer
SKUs across two sister sites, and $11,000 saved per SKU on every new tech transfer
<6 months
Materials qualified and ERP ready ahead of first GMP batch
88%
SKU library consolidation into modular, cross-site assemblies, reallocated through your existing ERP in weeks.
Results from separate Fastnet bio engagements with global biopharma companies and a biopharma CDMO. Client names withheld at their request.
How we engage
Choose how much of
the program we own.
Most clients hand us a deliverable or the full lifecycle, with one team accountable for the outcome. Where your team already owns the work, our specialists can support it directly.
See how the managed service works
Own a deliverable
One defined output, such as a qualification package, delivered complete.
Own the lifecycle
One accountable team from design through GMP release.
Strategic multi-site project
The full lifecycle on one standard, rolled out across your sites.
Support a team
Specialist GMP materials people, without the overhead of a full hire.
Materials qualified. Timeline protected.
Get your materials program under control. Start with a conversation.
