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.
We 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.
We 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.