Our Expertise
Biopharmaceutical Manufacturing & Supply Chain Operations
Specializing in optimizing manufacturing processes and value streams to ensure high-quality, GMP compliant, and efficient production of biopharmaceuticals. This involves strategic planning, implementing cutting-edge technologies, and continuous improvement practices to enhance productivity and product quality.
Cell Therapy Operations
Enhancing operations and execution for cell therapy products, from development through to commercialization. This includes optimizing workflows, ensuring regulatory compliance, and facilitating seamless transitions from R&D to market.
Quality Assurance
Implementing robust QA systems to maintain GMP compliance and quality standards across all processes. Specializing in end-to-end oversight of starting raw materials, organizational design, capacity and disposition planning, and strategic problem-solving to reduce recurring quality issues.
Building Facilities and Production Lines
Comprehensive support for new facility projects, including construction management, equipment procurement, commissioning, qualification (IQ/OQ/PQ), and process performance qualification (PPQ). Expertise in creating integrated schedules and managing multi-million-dollar budgets to ensure timely and cost-effective project delivery.