Sigma Node is a boutique consultancy bringing hands-on expertise in quality, regulatory affairs, supply chain, and analytical science to small manufacturers and startups in pharma, food, and medical devices.
We work with small teams building products in regulated industries — bringing the kind of senior, practical knowledge that is hard to hire full-time.
QMS design and implementation, GMP gap assessments, audit readiness, and Qualified Person (QP) support for pharmaceutical and healthcare manufacturers.
Regulatory strategy, dossier preparation, and submission support for pharma, food, and medical device products across major markets.
End-to-end supply chain assessment, logistics strategy, and resilience planning tailored to the operational constraints of regulated manufacturing.
ICP-MS method development and validation, laboratory data integrity, instrument qualification, and analytical data management.
Design of Experiments, statistical process control, and Lean/Six Sigma-informed process optimization for manufacturing and laboratory environments.
Scientific support for early-stage drug development, formulation strategy, and translation of pharmacological principles into manufacturable products.
Every member of Sigma Node has spent years doing the actual work in regulated industries. When we advise, it comes from experience — not a textbook.
Supply chain and logistics expert with deep experience optimizing complex manufacturing and distribution operations. Specializes in building resilient, compliant supply chains for companies operating in regulated and time-sensitive industries.
Pharmacist and pharmacologist with extensive GMP quality experience, including service as a Qualified Person (QP). Bridges the gap between scientific rigor and operational quality systems in pharmaceutical manufacturing.
Regulatory affairs specialist with expertise navigating approval landscapes for pharmaceutical, food, and medical device products. Helps startups build compliant pathways to market from day one.
Quality systems and process improvement engineer with expertise in ICP-MS, Design of Experiments, laboratory data management, and scripting for data analysis. Combines deep technical knowledge with a systems perspective to drive quality and efficiency in regulated manufacturing environments.
Small manufacturers deserve access to the same level of expertise that large companies build entire departments around. Our model is simple: senior practitioners, engaged on a flexible hourly basis, with no padding and no junior hand-off.
We've held the roles. We know what the work actually looks like.
We tell you what you need to hear, not what you want to hear.
Hourly engagements. No retainers required. No scope creep.
Pharma, food, medical devices. We stay in our lane.
Our engagements are underway. Client success stories and case studies will be published here as our work matures.
Case studies coming soon.
In the meantime, get in touch to discuss your specific challenge.