We design and build cleanroom environments aligned with 21 CFR Parts 210, 211, 212, and 1271 requirements, including HCT/P compliance and quality systems for clinical trials and commercial manufacturing.

From Phase 1 to Phase 3 clinical trials, we help clients design and scale cleanroom environments to support evolving production needs with full regulatory alignment.

Our experts support medical device and pharmaceutical clients in bringing new drug and biologic delivery systems to market through risk assessment, engineering design, program planning, and regulatory guidance.

We help pharmacies and healthcare facilities meet compounding standards through review of engineering and administrative controls, workflows, and environmental practices, with gap assessments and action plans.

Our team creates and updates SOPs for compounding operations to meet USP, FDA, and state requirements. We also provide staff training on aseptic techniques, gowning, HVAC systems, environmental monitoring, and more.

We design and commission cord blood banking facilities with a focus on FDA-compliant workflows, construction quality control, critical systems redundancy, and environmental monitoring protocols.

Our experts assess and mitigate HD exposure risks across healthcare settings. Ensure sustainable USP <800> compliance for pharmacy, nursing, and facility operations with guidance from our occupational health and toxicology experts.

We deliver comprehensive services from programming and design to modular/mobile swing space, commissioning, and as-built documentation – ensuring cleanroom performance, scalability, and flexibility.

Our team performs equipment IQ/OQ, ISO cleanroom certification, and continuous quality control. We help guide ongoing operations through environmental monitoring committee membership and regulatory audits.