Services

   Facility Strategy & Site Analysis 

Comprehensive evaluation of facility suitability, layout, and compliance potential. 

Regulatory Roadmapping 

Development of phase-appropriate cGMP strategies to ensure alignment from day one. 

User Requirements & Project Definition 

Collaborative development of URS and scope documents to guide success. 

   Design & Engineering Oversight 

Transform strategic intent into technical reality through expert design support. 

Vendor Selection & Management 

Identify and manage partners to deliver the highest quality cleanroom solutions. 

Construction Execution 

Oversee build-out aligned with cGMP, ISO 14644, and USP 797/800/825 standards. 

Commissioning & Qualification 

Plan and execute CQV activities to meet regulatory expectations with confidence. 

Validation Program Implementation 

Design and deploy cleaning, environmental monitoring, and validation programs. 

Quality Management Systems 

Implement robust QMS frameworks tailored to cleanroom operations and compliance. 

   Strategic Leadership Support 

Provide fractional leadership, interim expertise, and operational oversight. 

Lifecycle Optimization 

Ensure your cleanroom evolves with your business, maximizing performance and ROI. 

M&A & Growth Advisory 

Guide due diligence, private equity readiness, and expansion strategy.