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Manufacturing Solutions

We are a ​patient-focused ​global leader in advancing technical ​operations and providing manufacturing solutions from ideation through commercialization.​

We provide end-to-end services for the entire manufacturing lifecycle from pharma, to startup and established biotech including cell and gene, RNA-based, and radioligand therapies, CMO and CDMO, academia, financial institutions, and more. 

End-to-end manufacturing solutions

We provide global support with a proven track record of planning, building, and maintaining manufacturing facilities, capital expansions, and technical operations. 

  • Due Diligence & Business Strategy

    Due diligence and manufacturing strategy that considers, analyzes, and weighs every option.
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  • Owner’s Rep, Project Management & SME Backfill

    Specialized resources with proven expertise for all aspects of drug development.
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  • Project Scheduling & Controls

    Our project controls comprehensively manage scope, cost, schedule, and risks to keep manufacturing on time and within budget.
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  • Capital Project, Facility Builds & Tech Transfers

    We manage projects from end-to-end, including new facilities, capital expansions, and technical operations.
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  • Commissioning, Qualification & Validation

    We’ll CQV your entire asset life cycle—safely, and efficiently preparing you to achieve new capacity.
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  • Quality, Regulatory & Compliance

    Our QMS includes NC and CAPA programs, support for audits and regulatory submissions, and more.
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  • Automation & Controls

    Access system automation experts skilled in change control ownership, compliance, and data integrity.
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  • Supply Chain

    We optimize supply chain processes to improve efficiency and prepare for challenges.
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  • Operational Readiness

    Our experts supply the policies, procedures, and documentation for pre-approval inspections.
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  • Asset Lifecycle Management & Operations

    Apply quality-by-design principles to facilities management and operations, and asset lifecycle management and operations.
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Global Support for Complex Technical Operations​
Over 3,200 team members and over 40 offices in NA, EU, and APAC.
Deck Map 1

Proven track record of planning, building, and maintaining manufacturing facilities, capital expansions, and technical operations

Our resources, track record, and integrated approach provide a 5-15% savings by accelerating the delivery of your manufacturing facilities and capital projects.

  • 01. Plan & Design

    01. Plan & Design

    Plan & Design

    • Due Diligence & Business Strategy
    • Owner's Rep, Project Management, & SME Backfill
    • Project Scheduling & Controls
    • Capital Project, Facility Builds & Tech Transfers
  • 02. Build & Test

    02. Build & Test

    Build & Test

    • Commissioning, Qualification, & Validation
    • Quality, Regulatory, & Compliance
    • Automation & Controls
    • Supply Chain
  • 03. Deploy & Operate

    03. Deploy & Operate

    Deploy & Operate

    • Operational Readiness
    • Asset Lifecycle Management & Operations

People first and patient-focused

Our greatest resource is our people, with patients at the core of everything we do. Commitment to that value provides a foundation of success for us and our partners.

The preferred solution provider for global pharma organizations, pioneering the industrialization of 10+ commercial cell, gene, and novel therapies. And that’s just the start.

We have fulfilled over 100 tech ops partnerships with pharma, biotech, ​vaccines, cell and gene, mRNA, radioligand, academia, hospitals, financial institutions, CMO and CDMOs, ​med device, non-profits, and government agencies​.

100
tech ops partnerships
6
in tech ops capital investments
10
commercialized cell, gene, and novel therapies
60
facility builds and capital expansions