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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. 

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    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.

Clinical Reach

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.

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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