Our Work
Commissioning & Qualification Support for Complex, Regulated Manufacturing Programs
We support life sciences and regulated manufacturers with execution-focused CQV services across multi-site programs, greenfield builds, expansions, and remediation initiatives.
Due to client confidentiality agreements, some details are anonymized.
Supported multiple facilities across the U.S.
GMP / GxP-ready deliverables
From commissioning to final qualification packages
Works alongside Engineering, Quality, and Operations
Supporting life sciences manufacturers from greenfield startup through operational stabilization.
Representative CQV
Engagements
Select examples of how we support complex commissioning and qualification— including multi-site and repeat engagements. programs.
Global Bioprocessing Manufacturer — Multi-Site Commissioning & Qualification Program
Supported commissioning and qualification activities to enable operational readiness and quality alignment during a multi-site CQV program.
- Location(s): Multiple U.S. facilities
- Facility type: Bioprocessing and support utilities
- Systems supported: Process, clean utilities, and critical equipment
- Services: Commissioning, IQ/OQ, protocol execution, deviations, turnover packages
- Collaboration: Engineering, Quality, Validation, Operations, and vendors
- Outcome: Structured documentation and cross-functional CQV execution aligned with accelerated startup milestones.
Standards/Frameworks: GMP, GxP, ISPE Baseline, ASTM E2500
Large Life Sciences Manufacturer — New Build / Expansion Support
Led commissioning and qualification support for a new build and expansion program in a regulated manufacturing environment.
- Location(s): U.S. Northeast
- Facility type: Manufacturing and cleanroom support areas
- Systems supported: Utilities, automation, and facility systems
- Services: Commissioning, IQ/OQ/PQ, deviation support, turnover documentation
- Collaboration: Project engineering, site quality, and operations
- Outcome: Coordinated commissioning and qualification activities across disciplines to support on-schedule startup and strengthened inspection readiness
Standards/Frameworks: GMP, GxP, GAMP 5
Confidential Regulated Manufacturer — Remediation & Documentation Support
Provided remediation and documentation support to align existing systems with current quality and compliance expectations.
- Location(s): U.S.
- Facility type: Existing regulated manufacturing facility
- Systems supported: Legacy systems, documentation sets, and select utilities
- Services: Gap assessments, deviation remediation, documentation updates
- Collaboration: Quality, Validation, and Operations teams
- Outcome: Strengthened legacy documentation systems and deviation processes to improve inspection readiness and compliance alignment.
Standards/Frameworks: GMP, GxP
How We Support Projects
Our work typically includes one or more of the following.
Commissioning planning & execution support
Turnover/verification packages and traceability support
Risk-based approach alignment (where applicable)
IQ/OQ/PQ protocol development and execution
Deviation support and documentation remediation
Stakeholder coordination and schedule support
Environments We’ve Supported
Experience across highly regulated and hygienic manufacturing environments.
Bioprocessing & Life Sciences Manufacturing
Regulated Food & Beverage Manufacturing
Cleanroom & Controlled Utility Systems
Greenfield Facilities & Expansions
Startup & Operational Readiness Programs
Common Questions
Can you share specific client names or detailed project information?
In many cases, we must respect confidentiality agreements. We can share more detail during a qualified conversation and, when permitted, provide references.
Do you support single-site or multi-site work?
Both. We can support a single facility effort or scale across locations depending on project needs.
What project phases do you support?
We support efforts from commissioning planning through protocol execution and final turnover documentation, depending on scope.