CDMO SERVICES

Proven OEM Expertise. Trusted CDMO Partner.

Roncadelle Operations supports pharmaceutical and medical-device companies with development, industrialisation, cleanroom assembly and packaging — built for quality, traceability and scale.

Why Roncadelle

A CDMO built around protection, performance and compliance.

We combine engineering-led development with disciplined manufacturing execution — supporting projects from early feasibility through pilot lots and serial supply.

Fast-to-market

Structured phases from concept → industrialisation → commercial supply, with clear milestones.

Cleanroom execution

Controlled environments for assembly and packaging aligned with regulated-market expectations.

Traceability

Lot-level controls, documentation discipline and change control suitable for audits.

What we deliver

End-to-end CDMO services

Flexible engagement models to match your development stage, volumes and regulatory pathway.

Development & Industrialisation

  • Requirements definition & feasibility
  • DFM / DFA support and risk-focused design reviews
  • Prototype builds and pilot planning
  • Process development for scalable assembly

Manufacturing & Assembly

  • Precision molding and component manufacturing
  • Automated / semi-automated assembly
  • In-process controls and inspection strategy
  • Clinical-to-commercial scale-up planning

Packaging & Supply Readiness

  • Cleanroom packaging operations
  • Packaging configuration & labelling support
  • Batch documentation & release package alignment
  • Traceability and supply-chain integration

Infrastructure

Purpose-built facility for regulated production

A modern manufacturing footprint designed for controlled production, assembly and packaging —
supporting reliable output and scalable growth.

Typical partner outcomes

  • Reduced transfer risk via structured industrialisation
  • Repeatable performance through automation and process control
  • Audit-ready traceability aligned with customer requirements

Fast-to-market approach

From idea to market — with quality & compliance at the core

Clear phases, predictable deliverables, and project governance designed to accelerate timelines without compromising control.

Sustainability

Safer solutions — with lower environmental impact

We continuously invest in evidence-based sustainability initiatives to support our partners, stakeholders and patients.

Ready to discuss your CDMO project?

Send a short technical brief (product type, volumes, timeline). We’ll propose a clear path to industrialisation and supply.

Contact CDMO Team

CDMO SERVICES – FROM CONCEPT TO INDUSTRIAL SCALE

Closing the Industrialization Gap

Partner with Roncadelle to bridge the gap from engineering validation to automated, GMP-compliant, industrial scale production of injectable devices and packaging systems.

Development
CDMO

Industrialization
Gap

Industrial
Manufacturing

Bridge validated design directly into automated, GMP-compliant industrial scale.
  • Reduce fragmentation
  • De-risk automation
  • Accelerate ramp-up
  • Cconger Iremapt-up
  • Strengthen compliance
Roncadelle’s role: bridge validated development phases directly into sustained industrial production-without losing time at the handover.

Our CDMO Model - Design to Scale

Clear phases, predictable deliverables, and project governance designed to accelerate timelines without compromising control.

  • Design-to-scale programs for third-party clients
  • Verification & Validation discipline (EVT/DVT/ process validation support)
  • Regulatory-aware manufacturing under quality- compliant systems
  • Structured project management and transparent communication

Packaging & Device Programs

  • RTU / RTF packaging
  • Elph tray production
  • Rou latily-managgenatims worker szale's
  • Tub & tray production
  • Industrial manufacturing programs

Industrial Capabilities

  • Tooling
  • Automation
  • Cleanroom
  • Injection molding
  • Automation

Industrial Capacity & Infrastructure

+230 m" unit capacity

1,800 m 150 7 clearoom area