Solutions Through Collaboration
We partner with life science companies to transform processes, turn bold ideas into tangible solutions, and achieve results that turn “what if?” into “what is.”
Kumby — Founder & Principal Scientist
I’m a biopharmaceutical scientist with 20+ years’ experience across microbiology, quality systems and regulatory strategy. I work directly with teams to diagnose high-impact risks and deliver inspection-ready remediation and validation plans. When you engage me, you get hands-on leadership and clear, measurable outcomes.
Our approach
Our clients come to us to solve fundamental challenges in operations, quality control, validation, and remediation. We use a structured change-management approach — grounded in safety, integrity and trust — to orchestrate sustainable improvements.
1. Diagnose
Rapid evidence review and root-cause mapping to identify the highest-impact risks and constraints.
2. Prioritise
Focus on practical, high-impact interventions and quick wins that reduce regulatory exposure and cost.
3. Deliver
Provide SOPs, validation packages, training and handoffs — ensuring outcomes are implemented and sustained.
What we believe
Integrity
Transparent processes and the highest ethical standards guide our work.
Innovation
Continuous improvement and creative solutions to challenging technical problems.
Simplicity
We prioritise practical, implementable solutions over unnecessary complexity.
Belonging
We foster inclusive collaboration where every voice contributes to better outcomes.
Authenticity
We partner with humility, humor, and a commitment to results and team well-being.
Key collaborators & advisors
Dr. X — Senior Consultant (QA & Validation)
Lead: CQV programs and validation strategy. Available for project engagement.
Y — Regulatory Advisor
Regulator engagement and dossier strategy for local and ATMP pathways.
Z — Operations Specialist
Manufacturing scale-up, process optimisation and commissioning support.
Ready to transform your process or system?
We partner with ambitious teams to turn complex challenges into sustainable outcomes — let’s discuss how we can help.
Request consultation