Services
“Strategic Solutions That Drive Industry Excellence”
Industries Served
Pharmaceutical Manufacturing
At Nieuw Strategic Solutions, we specialize in Commissioning, Qualification & Validation (CQV), MES implementation, and Computer System Validation (CSV) to ensure full compliance with cGMP/GDP standards. We deliver efficient, risk-based solutions that support sterile and non-sterile production readiness. We work closely with cross-functional teams to drives regulatory compliance, operational excellence, and seamless project execution.
- End-to-End CQV Execution for clean and dirty utilities, upstream/downstream systems, and
critical manufacturing equipment - Equipment Requalification & Lifecycle Management
- Cleaning Validation
Construction Strategy & Management
We offer comprehensive support through the construction and turnover phases of capital projects—ensuring mechanical completion, system readiness, and smooth handover to client. With a strong foundation in compliance and execution, we bridge the gap between engineering, general/ sub-contractors, and quality to deliver timely, efficient, and compliant results. Our services include:
- Mechanical Completion Management
- System and P&ID Walkdowns
- Redline Drawing Review and Control
- Construction Turnover Package (CTP) Development & Oversight
- Punch List Tracking and Resolution
- Field Quality Audits and QA/QC Support
- System Readiness Coordination for Seamless Handover
- Compliance with Project Specs, cGMP, and Safety Standards
Life Sciences
We support pharmaceutical and biologics manufacturers with targeted solutions that ensure regulatory compliance, operational readiness, and product integrity. Our expertise spans system verification, utility qualification, and the integration of digital manufacturing platforms. Using risk-based methodologies aligned with ASTM E2500, we streamline validation while maintaining the highest quality standards. Our services include:
- System Verification & Commissioning
- Utility Qualification (Clean/Dirty Utilities)
- Implementation Support for Digital Manufacturing Platforms (e.g., MES, EMS, BAS)
- Risk-Based Validation Strategies aligned with ASTM E2500
- Documentation Development and Review (URS, IQ/OQ/PQ)
- Lifecycle Support for Regulated Systems
- Inspection Readiness and Audit Support
