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Providing Experienced Engineering, Manufacturing, RCM, Process Development, Quality, Quality Control, and Project Management Subject Matter Experts in support of our clients

  • Provide biopharma manufacturing facility conceptual Basis of Design (BOD), high-level schedule, and rough order of magnitude

    • Our experienced professionals lead our clients through the development of their conceptual BOD, high-level schedule, and project ROM that can then be presented to senior leadership for approval​

  • Lead the execution of our client's biopharma manufacturing facility Site Conceptual Design, Detail Design, Construction, Commissioning, Validation, and Readiness per Project Charter, Objectives/Deliverables, Budgets, and Key Performance Indicators per the established Integrated Project Schedule.

    • Establish/Manage Client projects, Request for Proposals, Bidding Assessments, Project Controls, and IPS in the successful execution of projects

    • Develop/Manage the execution of the Manufacturing, Quality Management Systems, QC Labs, Warehouse, Supply Chain Operational Readiness, and Process Mapping​

    • Oversee the Design, Construction, CQV, and MFG Readiness in support of the client's brownfield or greenfield clinical or commercial manufacturing facility site.

  • PTSI partners with our clients to establish an efficient design solution that meet their biopharma manufacturing requirements and all international regulatory standards and guidances while staying within budget.

  • Our biopharma professionals are real-world subject matter experts and anticipate the needs of our client's projects.  We have industry experts in all areas of focus.​​

    • Capital Projects Engineering​

    • Engineering/Facilities

    • CQV

    • Manufacturing

    • Process Development

    • Quality Assurance

    • Quality Control

    • Tech Transfer

  • Our biopharma operational experienced project managers offer flexible and dynamic solutions to drive each phase of the project. We employ strict project management principles to ensure on-time completion of all deliverables.

  • PTSI experts establish/manage the biopharma manufacturing facility environmental monitoring performance qualification (EMPQ) readiness, execution, and closeout.

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