Designing and operating a GMP-compliant facility is essential for manufacturing safe, effective, and regulatory-ready pharmaceutical products. Whether you're building a new cleanroom suite, expanding your manufacturing footprint, or transitioning from R&D to clinical production, we offer expert consulting in facility design and current Good Manufacturing Practice (cGMP) implementation.

Our services are tailored for complex modalities, including lipid nanoparticles (LNPs), polymeric drug delivery systems, sterile injectables, and nanomedicines—ensuring your facility supports both innovation and compliance.

Our Facility Design & GMP Compliance Services

1. GMP Facility Planning & Layout Design

We design functional, scalable, and compliant facilities for pharmaceutical manufacturing—balancing regulatory requirements with operational efficiency.
Includes:

• Facility conceptual design and layout optimization
• Material and personnel flow planning
• ISO cleanroom classification and zoning
• HVAC, pressure cascade, and utility specifications

2. Equipment Selection & Qualification

We help identify and integrate equipment that meets your process, scale, and regulatory needs.
Includes:

• User requirement specifications (URS) and equipment selection
• Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ)
• Process equipment compatibility with LNPs and sterile drug products
• Automation and instrumentation guidance

3. GMP System Implementation

Establish robust quality systems and documentation to meet FDA, EMA, and international cGMP requirements.
Includes:

• SOP development, batch record creation, and quality documentation
• Deviation, CAPA, and change control systems
• GMP training programs for technical and operational staff
• Preparation for regulatory inspections and pre-approval audits

4. Facility Start-Up & Tech Transfer Readiness

Ensure your facility is ready for technology transfer, scale-up, and GMP production.
Includes:

• Commissioning and qualification project management
• Cleaning validation and environmental monitoring setup
• Process integration with upstream/downstream workflows
• Support for engineering, clinical, and commercial batch production

Types of Facilities Supported

• LNP and nanoparticle formulation suites
• Sterile injectable and aseptic fill-finish facilities
• Pilot-scale and commercial GMP facilities
• Cleanrooms for advanced therapy and biologics
• Multi-product and modular manufacturing spaces

Why Choose Us

• Specialized focus: Built and managed GMP facilities for nanomedicines and LNP-based clinical products
• Regulatory alignment: Designs aligned with FDA, EMA, ICH Q7, and Annex 1 expectations
• Execution-ready: Practical guidance for every step—from layout to licensure
• Global experience: Supported facility projects across the U.S., EU, and Asia

Build with Confidence. Operate with Compliance.

Whether you're starting from the ground up or upgrading an existing facility, we help you design and operate a GMP-compliant environment that supports your product and mission.

📧 Contact us today to discuss your facility design or GMP implementation needs.