Your integrated partner for GMP materials.
Every batch.
Every site.
Free GMP maturity diagnostic
Estimate your project scope
Specialists on demand
Need depth in one workstream? Get specialist GMP materials people, without the overhead of a full hire
Fastnet Bio's specialists integrate directly into your systems and your team's cadence, run to an agreed plan, and hand back cleanly when the work is done. You get named expertise and a managed outcome.
See how the managed service works
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
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.
Free GMP maturity diagnostic
Estimate your project scope
Your integrated partner for GMP materials.
Free GMP maturity diagnostic
Estimate your project scope
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.
Free GMP maturity diagnostic
Estimate your project scope
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.
Free GMP maturity diagnostic
Estimate your project scope
Getting started with us
Three steps from requirements to delivery. Scoped, proposed and started within days.
.png)
Define scope
Receive proposal
Proposal built on your project data. Deliverables, timelines and resources defined before work begins.
Kick off work
PO received, team assigned, kick-off scheduled. Progress tracked and reported at each project milestone.
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.
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
01
Material Selection & Design
Translate process requirements into audit-ready assemblies, without costly redesign cycles.
Get to audit-ready faster.
DESIGN →
02
Supply Chain & ERP
Convert your GMP materials from a sourcing variable into a controlled, predictable asset.
Gain control of your supply chain.
SUPPLY CHAIN →
03
Qualification & Compliance
Build a qualification program that survives regulatory scrutiny and scales with your portfolio.
Build a scalable qualification program.
QUALIFICATION →
04
GMP Release & Sustain
Keep GMP workflows on track and inspection-ready, from first batch to ongoing compliance.
Stay inspection-ready from day one.
RELEASE →
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.