At Luathaich LLC, we believe in transforming challenges into opportunities and ideas into impact. Our mission is to provide biotech companies with a strategic advantage by combining deep technical expertise, operational excellence, and a culture-centered approach that ensures meaningful, sustainable results.
Led by CEO Bryan Gillis, Luathaich LLC delivers hands-on support across the entire drug development lifecycle—whether you’re navigating early-stage ideation and funding, scaling complex cGMP manufacturing, or building resilient CDMO partnerships. With over two decades of experience in biotech operations, Bryan brings a proven track record of leading transformative initiatives that bridge science, strategy, and execution.
We specialize in tackling the tough transformations others avoid. From operational setbacks to cultural resistance, warning letters, or consent decrees, we address not only the technical challenges but also the critical cultural shifts needed for lasting success. By aligning strategy with execution and empowering teams to embrace change, we help your organization regain momentum and move forward with confidence and purpose.
We are Lean practitioners with hands-on expertise from the shop floor to the C-suite. Our proven approach combines technical expertise with a focus on change management, ensuring durable, measurable, and impactful transformation. By addressing both systems and culture, we simplify complex challenges, empowering organizations to sustain excellence and drive continuous improvement.
At Luathaich LLC, we believe quality isn’t just designed—it’s lived. With expertise in remediating challenged systems, we help teams embed a culture of compliance and deep quality knowledge into daily operations. By bridging quality and manufacturing, we foster trust and alignment to build high-performing, unified teams. This culture of collaboration and accountability transforms quality from a regulatory obligation into the foundation of operational excellence and lasting success.
We specialize in overcoming obstacles that impede your therapies from progressing swiftly from concept to clinic. We excel in revitalizing stalled projects or programs, resolving operational challenges, and crafting communication strategies that align teams and drive execution. By reinvigorating critical projects and fostering clear, effective communication, we ensure stakeholders are engaged, processes are streamlined, and progress is accelerated. With LUATHAICH, you gain not just speed but the expertise to turn around challenges into impactful, lasting success.
We design and implement tailored change management frameworks that unify cross-functional teams, align leadership objectives, and embed a culture of collaboration to drive sustainable transformation.
From operational setbacks to consent decrees and regulatory challenges, we develop and execute rapid recovery strategies that stabilize operations, rebuild trust, and restore momentum.
We design and implement project management offices to drive accountability, enhance visibility, and ensure seamless execution of complex programs and initiatives.
We identify and eliminate inefficiencies across processes, systems, and workflows, leveraging Lean and Six Sigma principles to drive measurable improvements in performance, cost, and reliability.
We provide experienced, interim leadership to early-stage companies, de-risking programs, maximizing investor capital, and driving organizations toward their next critical financial or operational milestone.
Luathaich LLC support scaling and optimization of manufacturing processes, ensuring robust, compliant, and efficient production while mitigating risks and enhancing operational readiness.
We identify and eliminate inefficiencies across processes, systems, and workflows, leveraging Lean and Six Sigma principles to drive measurable improvements in performance, cost, and reliability.
We provide experienced, interim leadership to early-stage companies, de-risking programs, maximizing investor capital, and driving organizations toward their next critical financial or operational milestone.
We support scaling and optimization of manufacturing processes, ensuring robust, compliant, and efficient production while mitigating risks and enhancing operational readiness.
We build and refine quality systems that align with regulatory expectations, streamline operations, and reduce compliance risks across the product lifecycle.
Luathaich LLC develop strategies to anticipate and mitigate compliance risks, ensuring your organization is prepared to meet regulatory demands with confidence and efficiency.
We resolve regulatory challenges and remediate quality systems after issues arise, stabilizing operations, restoring compliance, and rebuilding trust with stakeholders and authorities.
We revitalize stalled or troubled technology transfers, ensuring seamless knowledge transfer, alignment across stakeholders, and successful scale-up for clinical or commercial production.
We streamline development processes and project management strategies to eliminate bottlenecks, align priorities, and accelerate progress from concept to clinic.
We craft clear, actionable communication strategies to align teams, engage stakeholders, and drive execution, ensuring rapid and sustainable results.
Rescued a seed-stage company from a 6-month delay, delivered $320K in real savings, and reestablished investor confidence within 90 days.
Increased maximum output by 23%, enabling ~ $236M in product sales through durable cultural, operational, and process improvements.
Restarted a stalled Phase III trial by resolving an FDA clinical hold in 60 days and an internal quality hold in 30 days (vs. industry average of 186 days), providing $2.5M in cost avoidance.