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.