Integrated, GMP-aligned Manufacturing
Capabilities
Are you looking for established and proven medtech engineering, manufacturing, and quality expertise?
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Contract Manufacturing
Our Capabilities
Quvara provides GMP-compliant contract manufacturing for pharma and biotech customers requiring absolute confidence in product integrity, process control, and continuity of supply.
Manufacturing operations run continuously, supported by automated and semi-automated assembly lines, over 50 injection moulding machines, ISO Class 7 & 8 cleanrooms, and in-line inspection. On-site prototyping and test method development enable rapid iteration and robust process control.
This delivers predictable scale-up, reduced lifecycle risk, and confidence that manufacturing will not constrain commercial success.
Quality & Validation
Quality and validation are foundational capabilities at Quvara. We provide full lifecycle validation services including IQ, OQ, PQ, equipment qualification, ISO 14971 risk management as part of FMEA, electronic batch records, automated release, and real-time quality trending. Systems are fully compliant with ISO 13485 and FDA 21 CFR Part 820, ensuring continuous inspection readiness.
Engineering
Quvara’s capabilities include expert moulding process optimisation coupled with material selection advice to ensure a repeatable process window is achieved. Other in-house resources include spring design and manufacture, automation expertise and data systems design. Continuous improvement and robust cost control are employed in all development projects and ongoing through series production.
Industrialisation
Quvara’s industrialisation teams ensure products transition efficiently from design intent to validated commercial manufacture. Capabilities include DFM, DFA, DFI working closely with our clients to optimise designs for efficient, streamlined production. We also ensure processes are designed to scale for moulding, assembly and testing to future proof manufacture and support smart investment decisions.
Prototyping Scale-up & Transfer
We support rapid prototyping, controlled scaleup, and efficient industrial transfer through integrated, GMP aligned manufacturing capabilities. In-house 3D printing, test method development and advance metrology reduce risk and accelerate development. Expertise in materials, tooling, packaging, labelling, process development and pilot production design, optimise manufacturing and support scaling and full automation.
Programme & Project Management
Strong governance, robust stage-gate project management with integrated master planning, ensures a smooth, regulatory compliant journey from concept to series production. A risk-based approach with requirements traceability support validation through IQ/OQ/PQ phases. Financial controls, partner integration, collaborative and transparent communication tools and processes, reduce risk to deliver projects on time and on budget.
Microbiology
Quvara operates fully integrated, in-house microbiology aligned with EU GMP and global regulatory expectations. We support routine environmental monitoring, cleanroom performance trending, and timely investigation of microbiological deviations, forming a core part of our contamination control. This integrated approach provides regulators and customers with confidence in product quality, process control, and long-term supply reliability.
Metrology
Quvara Medical’s metrology capabilities provide precise, repeatable measurement and analysis using advanced tools such as automated CT scanning, optical and mechanical CMMs, and structured data outputs to ensure dimensional accuracy and design integrity. Material and functional performance testing, thermal analysis, mechanical testing, and durability assessments, identify variability early and maintain compliance.
Packaging & Labelling
Packaging and labelling are fully integrated into Quvara’s regulated and digitised manufacturing workflows. Capabilities include cleanroom packaging, serialisation-ready workflows and integration with validated quality systems, supporting efficient global market release. We have an electronic batch release and label verification system to ensure continuous compliance and full traceability.
Sustainability
Quvara demonstrates longstanding, award winning sustainability leadership through achievement of global performance targets, continuous improvement Kaizen initiatives, lifecycle assessments, and data driven environmental metrics. The organisation embeds ESG principles through frameworks like EcoVadis, collaborates with suppliers and customers and treats sustainability as a core operational discipline.
Supply Chain & Procurement
Quvara manages complex, regulated supply chains with a focus on resilience, transparency, and compliance. Capabilities include supplier qualification, dual-sourcing strategies, capacity planning, and full material traceability — reducing exposure to shortages, disruptions, and compliance risk. Suppliers are part of our continuous improvement process to jointly delivery year on year savings
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