Synthetically Augmented Consulting saves you time and money.

 Since 2017, Cutler Consulting, LLC. has always been built on humility and diligence.

A decade before “Super Intelligence” arrived, we were already serving Fortune 500-scale enterprises as well as tiny startups.

Now, we leverage SI for our clients in the right way: to speed up delivery, to increase reliability, and to substantially elevate the final polish.

As our client: you can rest assured that SI will never be deployed irresponsibly behind the scenes—nor will its tremendous value be neglected in favor of billing senseless hours like the outdated consultants of the prior era.

We will never lag behind; in fact, we challenge you to keep up.

SERVICE OFFERINGS

Full-Stack Assurance (FSA)

Integrated regulatory, quality, security, and assurance expertise.

  • FDA and EU submissions, global market access, regulatory pathway development, labeling, claims strategy, and commercialization across medical devices, pharmaceuticals, biologics, cosmetics, dietary supplements, and combination products.

  • QMS and eQMS design, implementation, modernization, and remediation; enterprise risk management, audits, supplier quality, inspection readiness, and international standards compliance.

  • Information security management in compliance with select international industry standards, regulated software validation and CSA, data integrity, electronic records, cybersecurity risk management, and enterprise information governance.

  • Super Intelligence governance, system validation, human-in-the-loop process implementation and training, SI/AI risk management to select international standards, performance evaluation, and integration into regulated enterprise systems.

Operations, Product Development, & Industrial Scaling

  • Hardware and software product development, requirements engineering, design controls, technical architecture, verification, validation, and manufacturing transfer.

  • Manufacturing-system development, process optimization, production readiness, supply-chain integration, supplier management, and industrial scale-up.

  • Cross-functional operational leadership, organizational restructuring, process standardization, enterprise systems integration, and execution of complex transformation programs.

  • Enterprise SI adoption, workflow automation, process redesign, system integration, deployment governance, and human-supervised operational scaling.

EXTREME PROBLEMS. EXTREME RESULTS.

ENTERPRISE OPS & GLOBAL COMMERCIALIZATION

Global Biomedical Technology Enterprise

Multi-billion-dollar parent organization | Metrology

Multinational Consumer Products Enterprise

Multi-billion-dollar global organization | Opthalmology

ARTIFICIAL INTELLIGENCE, ADVANCED MEDTECH, & PRODUCT DEVELOPMENT

International Medical AI Innovator

Early-stage MedTech company | Cardiology

International Advanced MedTech Manufacturer

Specialized manufacturer | Interventional medicine

Medical Equipment & Software Manufacturer

Specialized manufacturer | Otolaryngology

Advanced Surgical Robotics Developer

Development-stage manufacturer | Gynecology

Specialized Medical Device Developer

Global MedTech manufacturer | Sepsis diagnostics

MedTech Startup

Development-stage venture | Orthopedics

Emerging MedTech Manufacturer

Clinical-stage startup | Audiology

Consumer Health Tech Startup

  • Served as principal regulatory and quality advisor to senior leadership across a diverse international portfolio of medical devices, pharmaceuticals, and combination products.

  • Directed regulatory strategies, quality-system remediation, claims substantiation, labeling, product risk management, and commercialization planning.

  • Identified serious product-quality and safety risks overlooked by earlier supplier assessments, escalating findings and recommending corrective actions and supplier disqualification.

  • Led international supplier qualification, compliance auditing, and remediation across manufacturing, distribution, and regulated service providers.

  • Developed global regulatory strategies, operating budgets, licensing plans, and implementation requirements for concurrent commercial development programs.

  • Advised clinical affairs and commercial leadership on evidence strategy, CRO selection, and the regulatory implications of proposed clinical investigations.

  • Directed pharmaceutical distribution-compliance initiatives, including licensing and product-integrity controls.

  • Directed U.S. market-entry strategy for an AI-enabled medical technology, integrating regulatory pathway selection, clinical evidence, design controls, cybersecurity, validation, and submission readiness.

  • Identified approximately $200,000 in regulatory expenditure savings through strategic planning and improved execution.

  • Evaluated six competing clinical research vendor proposals, resolving scope duplication and accountability gaps to reduce the projected clinical budget by approximately $500,000.

  • Coordinated an international multidisciplinary team spanning clinical specialists, scientists, software engineers, and regulatory and quality professionals.

  • Led operating-model improvements connecting research objectives, clinical evidence requirements, vendor management, and executive accountability.

  • Led FDA and EU regulatory strategy for advanced medical technologies involving software, machine learning, and combination-product requirements.

  • Directed product risk management, design controls, quality-system implementation, and multidisciplinary technical documentation.

  • Developed pharmaceutical design documentation and contributed to international device regulatory filings.

  • Addressed sensitive FDA inspection-related compliance matters.

  • Integrated software governance, labeling, medical-device requirements, and drug-development controls into coordinated regulatory planning.

  • Directed FDA 510(k) strategy, product risk management, software assurance, and cybersecurity planning for regulated medical devices and software.

  • Led quality-system gap assessments, internal audits, FMEA, computer-system validation, and regulatory remediation.

  • Addressed significant FDA inspection-related observations and associated compliance requirements.

  • Authored cybersecurity documentation for inclusion in FDA submission materials.

  • Integrated FDA, ISO, IEC, and recognized cybersecurity standards into submission readiness and regulated software-development strategy.

  • Led and supported regulatory and quality activities for a complex Class III robotic surgical platform integrating electromechanical systems, software, and advanced medical technology.

  • Contributed to FDA PMA strategy, Canadian medical device licensing, and European regulatory submission documentation.

  • Led manufacturing documentation and quality-engineering activities covering fabrication, component inspection, process controls, and certification planning.

  • Helped implement an ISO 13485 quality-management system, contributing to successful certification with no major findings.

  • Directed and supported product risk management, FMEA, CAPA, computerized-system validation, usability, software lifecycle controls, and supplier oversight.

  • Participated in design-change governance with senior engineering leadership for a highly complex, multidisciplinary surgical platform.

  • Directed regulatory strategy, quality-management systems, product risk management, and submission readiness for regulated diagnostic technologies.

  • Authored FDA 510(k) and European regulatory technical documentation.

  • Led electronic quality-system initiatives, labeling strategy, organizational quality processes, and design controls.

  • Integrated biological safety, product-risk requirements, and international regulatory expectations into product-development documentation.

  • Advised FDA 510(k) regulatory strategy and pathway decisions for a Class II medical device.

  • Evaluated labeling strategy, regulatory evidence requirements, and product-development considerations.

  • Applied FDA and ISO requirements covering quality systems, product risk management, biological safety, and electronic-record governance.

  • Served as interim quality executive and advisory-board member, advising leadership across engineering, procurement, supplier management, IT, and organizational operations.

  • Directed quality-management, eQMS procurement, design controls, product risk management, CAPA, auditing, and validation activities.

  • Managed senior engineering and quality personnel while coordinating cross-functional development and operating priorities.

  • Supported regulatory submission preparation, supplier oversight, and international development activities.

  • As an embedded VP, advanced the company's product-development program to successful FDA 510(k) clearance.

  • Served as interim VP of Quality and board advisor, establishing regulatory and quality-management infrastructure from the ground up.

  • Directed supplier qualification, internal audits, SDLC, product risk management, training, and document-control systems.

  • Led eQMS procurement, product certification planning, and usability-validation activities.

  • Managed engineering and quality personnel while advising executive leadership on FDA regulatory strategy, labeling, and commercialization readiness.

Biomedical VR Startup

Early-stage venture | Pain Management

BIOTECHNOLOGY, PHARMACEUTICALS, & DRUG DEVELOPMENT SOFTWARE

Public Biotech Developer

Eight-figure annual revenue | Immunology

Public Biotech Developer

Eight-figure annual revenue | Oncology & Immunology

Early-stage venture | Audiology

  • Established a foundational quality-management system and regulatory strategy for a Class II medical technology incorporating custom software.

  • Directed product risk management, design controls, regulated-software governance, and quality documentation.

  • Integrated FDA medical-device requirements with relevant ISO and IEC standards covering software, risk, and medical electrical equipment.

  • Advised top management in regulated quality management and IT operations supporting investigational drug and biologics development.

  • Directed computerized-system validation, electronic-record governance, software lifecycle controls, and product-related risk management.

  • Developed SOPs, work instructions, and compliance documentation supporting regulated scientific programs.

  • Integrated pharmaceutical, biologics, software, and electronic-record requirements into multidisciplinary research and operating systems.

  • Directed cross-functional quality-management and IT operations supporting investigational drug and biologics programs.

  • Led computerized-system validation, regulatory compliance audits, electronic-record governance, and risk-management activities.

  • Coordinated international quality and technology workstreams supporting oncology and immunology development.

  • Strengthened regulated operating processes, software compliance, and documentation controls under FDA pharmaceutical and biologics requirements.

  • Managed regulatory and quality operations supporting translational research, experimental therapeutics, and clinical evidence generation.

  • Established and managed the development and validation lifecycle for a custom laboratory information management system, integrating requirements, documentation, change control, and quality-system controls.

  • Supported research activities involving histology, biomarker assays, analytical software, and investigational drug-development evidence.

  • Coordinated scientific, clinical, engineering, and software teams around regulated research workflows and data integrity.

  • Supported regulatory and product-development strategy for advanced therapeutic and combination-product research.

  • Conducted a targeted regulatory and information-security compliance audit of clinical research software operations.

  • Evaluated HIPAA, 21 CFR Part 11, privacy, cybersecurity, electronic records and signatures, validation, and procedural controls.

  • Delivered documented audit findings and corrective-action recommendations addressing clinical data integrity and regulated software compliance.

  • Established a quality-management system integrating biotechnology research operations, custom scientific databases, and regulated software development.

  • Directed regulatory strategy, software risk management, electronic-record compliance, and product governance.

  • Developed documentation and lifecycle controls supporting both research services and software-enabled medical technology.

  • Connected scientific research processes with regulated-product quality requirements.

  • Established regulatory and quality-management infrastructure from the ground up for pharmaceutical information systems and regulated software.

  • Directed software risk management, labeling, electronic-record compliance, and product governance.

  • Integrated FDA Part 11, ISO 13485, and ISO 14971 expectations into software-development and quality operations.

CONSUMER PRODUCTS, COSMETICS, & DIETARY SUPPLEMENTS

Translational Biotech Research Organization

Clinical-stage biotechnology | Oncology

Clinical Research Tech Startup

Specialized CRO | Clinical Trial Software

Biotech Research Software Startup

Early-stage venture| Proteomics & Genomics

Biotech Research Software Startup

Early-stage venture | Pharmaceutical Informatics

  • Developed the world's first 100% organic alternative to conventional synthetic floral foam, translating biodegradable-materials research into a functional consumer product.

  • Provided chemical and materials engineering, product design, manufacturing optimization, and regulatory support.

  • Evaluated EPA-related chemical and environmental compliance considerations, including TSCA applicability, material composition, and manufacturing waste-management requirements.

  • Supported environmental-performance evaluation and substantiation considerations concerning biodegradability, product disposal, and sustainable-material claims.

  • Contributed to laboratory information-system validation, electronic quality-system implementation, and commercialization activities.

  • Supported manufacturing-process optimization, supply-chain planning, materials characterization, and regulatory strategy.

  • Conducted plastics and silicone-materials analysis supporting novel industrial product development.

  • Fabricated functional high-performance prototypes using recycled laboratory-derived polymers, translating biotechnology waste streams into practical engineering applications.

Sustainable Consumer Products Startup

Early-stage venture | Floral Design & Horticulture

Advanced Materials and Biotech Startup

Early-stage venture | Polymer Engineering

  • Led cross-functional modernization spanning regulated manufacturing, enterprise quality management, engineering operations, cybersecurity, AI governance, and supplier controls.

  • Architected an integrated management-system implementation plan harmonizing FDA QMSR, ISO 13485, ISO 9001, ISO 27001, ISO 42001, NIST frameworks, and FDA Part 11 requirements.

  • Redesigned the underlying manufacturing data architecture, integrating products, personnel, equipment, training, software, qualification, risk controls, and auditable evidence.

  • Led recovery planning for a complex manufacturing system, rebuilding the requirements, design, risk, verification, validation, and operational-release approach.

  • Redesigned regulated training processes, reducing documentation requirements by approximately 50% while strengthening competency controls.

  • Established integrated AI governance, cybersecurity assurance, risk escalation, and incident-management mechanisms.

  • Assumed leadership responsibilities previously distributed across a large external consulting team; developed efficiency improvements projected to substantially accelerate regulated operations.

  • Led regulatory and quality strategy across cosmetics, surface cleaners, dietary supplements, OTC pharmaceuticals, and consumer-health products regulated across FDA, EPA, and state regulation.

  • Directed multi-regime claims substantiation and labeling strategy, challenging unsupported commercial claims and development approaches that introduced regulatory or commercialization risks.

  • Applied diverse FDA, EPA, and state regulatory frameworks covering cosmetic products, dietary supplements, pharmaceutical manufacturing and distribution, labeling, surface sanitizers, and quality assurance.

  • Directed international supplier qualification, manufacturing audits, and compliance remediation across overseas suppliers and regulated service organizations.

  • Led pharmaceutical distribution licensing and Good Distribution Practice initiatives addressing product integrity, storage, traceability, and market readiness.

Global Consumer Health & Beauty Portfolio Holder

Multi-billion-dollar multinational | Vision Care & Consumer Wellness

  • Provided chemical-engineering expertise supporting the development of silicone-based consumer lunchware.

  • Advised polymer-material suitability, product quality, manufacturing considerations, and quality-management strategy.

  • Considered environmental materials and manufacturing-waste implications alongside product safety and food-contact requirements.

  • Contributed marketing and commercialization advice, connecting technical product characteristics with consumer positioning and market opportunities.

Consumer Products Developer

Early-stage venture | Food Storage

  • Advised on fabrication of custom high-performance kayaks using recycled laboratory plastic waste, transforming specialized biomedical waste streams into functional recreational watercraft.

  • Provided plastics and materials systems engineering support, including polymer characterization, material suitability, and manufacturing-process optimization.

  • Contributed EPA materials compliance and RCRA-related waste-management assessment, addressing waste classification, potential chemical contamination, recycled-material handling, and lawful recovery and reuse.

  • Evaluated applicable TSCA and RoHS chemical and polymer considerations associated with recycled feedstocks, additives, and material suitability. • Supported quality engineering, supply-chain strategy, plastics and silicone analysis, and manufacturing optimization.

  • Demonstrated practical applications of sustainable manufacturing and laboratory-waste recovery in consumer-product engineering.

  • Architected integrated SI and information-security governance systems, aligning enterprise technology adoption with operational accountability, validation, cybersecurity, and regulated information management.

  • Redesigned manufacturing data architecture to connect products, markets, personnel, equipment, software, qualification, maintenance, training, and controlled evidence.

  • Established SI risk-management, incident-escalation, and corrective-action mechanisms, integrating automation with human oversight and existing quality processes.

  • Identified previously unrecognized cybersecurity exposures across company and facility infrastructure.

  • Unified electronic-record requirements, software assurance, information-security standards, and SI governance within existing operating systems.

  • Established and managed the software development lifecycle for a custom laboratory information management system supporting advanced biomedical research.

  • Directed software requirements, system validation, documentation, change control, and integration with regulated research operations.

  • Connected laboratory workflows, analytical data, scientific evidence, and quality-management requirements within a coherent software governance framework.

  • Coordinated scientists, engineers, software developers, and research personnel to align technical implementation with clinical research and FDA-facing development requirements.

Green Tech Startup

Multi-billion-dollar parent organization | Manufacturing Informatics

Early-stage venture | Recreational Watercraft

Global Technology Manufacturer

Translational Research Software Developer

Multi-billion-dollar parent organization | Manufacturing Informatics