Level up your material

design

qualification

supply chain

We embed with your biopharma teams to design, introduce & manage GMP materials. Ready for every batch, every site.
Estimate my project's scope
Continuous Improvement
Stakeholder Management
Project Management
Material Management
Supplier Notifications of Change
Change Control Support
SU Library
Particulates Qualification
Cross Welding Qualification
Process Agnostic Qualification
Root cause analysis
Validation Master Plan
Raw Material Release
Continuous Improvement
Stakeholder Management
Project Management
Material Management
Supplier Notifications of Change
Change Control Support
SU Library
Particulates Qualification
Cross Welding Qualification
Process Agnostic Qualification
Root cause analysis
Validation Master Plan
Raw Material Release
Contamination Control Strategy
SU Cost Analysis
Material Specification
SU Integrity Qualification
SU Process Visualization
SU standardization
URS Development
SU Waste Management
Design Qualification
Procurement Support
Sustainability Assessment
Dual Sourcing
Extractables and Leachables
Contamination Control Strategy
SU Cost Analysis
Material Specification
SU Integrity Qualification
SU Process Visualization
SU standardization
URS Development
SU Waste Management
Design Qualification
Procurement Support
Sustainability Assessment
Dual Sourcing
Extractables and Leachables

Trusted by

Eli Lilly logo
GSK logo
MSD logo
Takeda logo
Resilience logo
Tonix pharmaceuticals logo

Our solutions

Our solutions qualify materials faster, cut supply chain risk and keep your facility inspection-ready.
design
GMP material specifications structured and audit-ready before qualification begins. No rework, no gaps.
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Qualification
Qualification frameworks and SOPs built for reuse across molecules and sites. Faster timelines, fewer deviations, audit-ready by default.
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Supply Chain
Vendors qualified upfront. Materials tracked. Change notifications managed. No supply surprises at batch time.
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Sustainability
Sustainability assessment integrated into your materials program. Net-zero targets met without disrupting compliance.
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Getting started with us

Three steps from requirements to delivery. Scoped, proposed and started within days.
Define scope
Share your material requirements, timelines and site constraints. We turn that into a defined scope with clear deliverables.
Use our calculator →
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.
Get to know us →

Testimonial

“An absolute pleasure to work with. They’ve allowed us to focus on construction and installation, safe in the knowledge that all our materials are compliant.”
— Mark Maselli, Associate Director of Operations, Tonix Pharmaceuticals

Join the team

We’re looking for talented individuals with diverse perspectives to help power our mission and guide our clients to success.
Open positions

Materials qualified.
Timeliness protected.

Talk to the team.
Get your GMP materials under control.
Let's talk
Your Integrated GMP Materials Partner.
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