Our Approach
- CompliScience Solutions provides science and risk-based, regulator-aligned consulting services to support the design, build-out, commissioning, and validation of cGMP-compliant facilities for biopharmaceutical manufacturing, cell and gene therapy, CDMOs, sterile compounding, and academic cGMP operations.
- Modern GMP facilities must do more than look compliant on paper…they must be designed to control contamination risk, support aseptic operations, enable proper personnel and material flow, and withstand regulatory inspection.
- We help clients translate regulatory expectations and scientific risk into practical, defensible facility designs that embed compliance directly into the physical architecture of the operation.
- Our team brings hands-on experience designing and launching real cGMP facilities…from small cell-therapy suites to large biomanufacturing and sterile compounding operations.
- We work alongside owners, engineers, architects, and cleanroom vendors to ensure facility layouts, ISO classifications, airlocks, utilities, and workflows are aligned with FDA, EMA, ICH, USP, and ISO 14644 expectations.
Our support includes:
Facility layout and flow strategy (personnel and material segregation)
ISO classification and cleanroom zoning strategy
PAL/MAL and airlock design
Contamination Control Strategy (CCS) development
Risk-based facility FMEAs and compliance matrices
URS and Basis of Design (BOD) development
Design review and regulatory defensibility assessments
FDA Type C facility meeting preparation
Utility and equipment placement strategy
Commissioning, qualification, and validation planning
Rather than relying on procedures to compensate for poor design, we embed risk controls and regulatory requirements directly into the facility itself.
The result is a right-sized, inspection-ready cGMP facility that reduces contamination risk, supports efficient operations, and stands up under regulatory scrutiny.
