Offering full-service site evaluation, master planning, architectural design, engineering, procurement, and construction capabilities for GMP manufacturing, research and development, process support, facilities and utilities, O’Neal provides a total solution. Added to these capabilities is in-depth regulatory compliance with FDA and CBER regulations, and cGMP and ISPE best practices.
Focus Areas:
- Aseptic manufacturing
- Biopharmaceuticals
- Blood products
- Bulk pharmaceutical chemicals
- Cell + gene therapy
- Dietary supplements
- Industrial biotechnology
- Medical device
- Oral solid dosage
- Parenteral therapeutics
- Pharmaceuticals
- Potent compounds
- Probiotics
- Vaccines
special capabilities:
- Integrated planning, design + construction services geared for regulated life sciences industries
- In-house design expertise in biotech + pharmaceutical manufacturing processes, regulatory compliance, hygienic/aseptic technology, cleanrooms, HVAC + process utility systems
- Long-term industry experience + specialized knowledge, to handle cGMP facility delivery from initial planning + concept development through detailed design, procurement + construction
- Facility delivery for complex, technology + compliance-driven design requirements through full-service capabilities to operate within a cGMP environment
Services:
- Planning
- Site selection support
- Facility programming
- Conceptual design
- Preliminary engineering
- Detailed design
- Procurement
- Construction
- Process feasibility studies
- GMP equipment design
- Process modeling
- Technical consulting
- Operations improvement
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