About
Your Mission—Our Strategy…Expedited results that Maximize Value.
Our Story
Our Expertise
From implementing regulatory frameworks like Design Controls and Unique Device Identification (UDI) to streamlining validation processes and eliminating non-value-added costs through process optimization, our expert consultants deliver practical, compliant and results-driven solutions—on time and with minimal disruption.
We help life science & manufacturing companies navigate complex challenges, enhance critical systems and scale operations with confidence.
Our Value
Our ability to deliver swift, impactful solutions has consistently led to extended engagements and deeper client relationships. Organizations trust us to not only address immediate challenges but also to provide long-term strategic guidance that ensures sustainable growth and compliance.
Experienced industry experts teamed up to help you with your operational & regulatory needs
Phillip A. Minton
Lead Consultant—Plant/Company Consolidations,
Design & Process Controls, Quality Systems
Alan Leeds
Lead Consultant- Strategic Leadership, CASCADE G&Os & Agile (SCRUM) Execution
Julius Walker
Lead Consultant- CQV, Site Initiation & Validations
Ben Mangawang
Lead Consultant- Business Intelligence, MES, & SCADA Validations
Heather Kauth
Senior Consultant- Quality & Process Engineering
Expediting your Mission…
Fast, Flexible, Focused
Our ability to deliver measurable results comes from a proven approach built on speed, adaptability, attention to detail, and a focus on lasting impact. These four pillars define how we work and why our clients trust us to navigate their most critical challenges.
Speed
Speed
Business priorities shift, regulations evolve, and market demands change overnight. Our agile execution model allows us to adapt in real time, adjusting resources, timelines and strategies so your initiatives keep momentum and achieve their objectives
Agile Execution
We understand that in regulated industries, delays cost more than time—they impact market opportunities and compliance. Our team engages quickly, deploying proven frameworks and experienced specialists to deliver results without unnecessary lag.
Thoroughness
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Risk Mitigation
Our focus extends beyond project delivery. We design solutions that strengthen your operational foundation, enhance scalability, and create a pathway for sustainable growth, enabling your business to thrive long after the engagement ends.
Strategic Growth
We don’t just check the boxes—we dive deep into every process, requirement, and potential vulnerability. By identifying risks early and implementing targeted controls, we safeguard quality, ensure compliance and protect your investments.
