Stay Compliant With Total Quality and Regulatory Management Want to work with a Top Quality & Regulatory Professional with over 15 years in QA/RA Management in the Food, Supplements, and Cosmetics space? If you’re looking for support in the following areas then you're in the right place! CORE AREAS OF SUPPORT o Supplier Quality - management, auditing, sourcing, SCAR, CAPA o Product Testing - consulting, review, FG release o Finished Good Specifications - creation, revisions, review o Regulatory Compliance - product listing, claims substantiation, regulatory submissions o Product Review - label review, marketing materials, o Consumer Complaints - management, investigations, review, SAER, reporting & dashboards o General Consulting - cGMP, DSHEA, FSMA, FSVP, HACCP, MoCRA If your goal is to validate compliance, identify regulatory gaps, and implement systems that withstand FDA scrutiny, I can help. My Industry Certifications & Training: BS Food Science, HACCP, cGMP, CP-FS, ASQ CQA, CQE **Important Note** If you’re looking for cheap mediocre work, then I’m not the person for you. HOW I WORK: I work best with serious brands that view compliance as a long-term growth strategy, not a last-minute fix. If you're serious about your business then I’m serious about contributing to your success! Projects are structured in clearly defined milestones with documented deliverables and practical implementation guidance. NEXT STEPS: Send a brief overview of your product category, number of SKUs, and project objectives. If aligned, we’ll schedule a short strategy call to confirm scope and timeline.

Dan Simonsen is the founder of SIG Consulting, a boutique firm that helps food, dietary supplement, and import companies work through FDA compliance issues.Before starting the practice, Dan spent his career at FDA's Office of Import Operations, most recently as a Compliance Officer, where he directed enforcement actions and advised importers on admissibility requirements across the food, supplement, and consumer product space. That background means he's spent years on the side of FDA that inspects and enforces, and he now uses that perspective to help companies get ahead of problems or work their way out of them.Dan's focus areas include import hold and detention resolution, Form 483 and Warning Letter response, and building FSVP programs that can actually stand up to inspection.

I help food and supplement businesses pass audits, resolve compliance gaps, and build food safety systems that actually work in real manufacturing environments. With 5+ years of hands-on experience in food manufacturing QA and regulatory compliance, I support companies across Canada (CFIA), the US (FDA/FSMA), and the EU with practical, inspection-ready documentation and compliance support. I specialize in turning regulatory requirements into clear, usable systems; not generic templates. Typical projects I support: • CFIA Preventive Control Programs (PCPs) and HACCP-based food safety systems • FDA/FSMA compliance support (PCQI-aligned documentation, gap analysis) • GMP and prerequisite program development • Audit preparation, corrective actions, and follow-up support • Food safety risk assessments, traceability, and recall readiness • Label and regulatory review for market access I’ve worked directly inside food manufacturing operations, which means I understand production flow, people, equipment, and the realities inspectors expect to see, not just what regulations say on paper. If you need fast, competent support to prepare for an audit, fix gaps, or maintain compliance without overcomplicating your operation; I can help.

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Quality Management Specialist with over 8 years of experience driving excellence in regulated environments across engineering, manufacturing, and operational settings. My passion lies in building quality systems that don't just meet compliance requirements—they create tangible business value through improved accuracy, reduced risk, and enhanced operational efficiency. Throughout my career, I've specialized in transforming complex regulatory requirements into practical, sustainable quality processes. Whether implementing an FSSC 22000-certified food safety management system, managing comprehensive QMS documentation repositories with 1,000+ controlled documents, or reducing quality incidents by 60% through data-driven root cause analysis, I focus on solutions that deliver measurable results. What I bring to the table: Quality Systems Leadership – I've developed and maintained quality management systems aligned with ISO 9001, API Q1, cGMP, and FDA/FSMA requirements, ensuring both regulatory compliance and operational excellence. Audit & Compliance Excellence – As a primary liaison for third-party audits and regulatory inspections, I've consistently achieved successful outcomes through meticulous preparation, gap analysis, and corrective action management. Documentation & Process Improvement – From designing document management procedures to establishing structured review processes that reduced documentation errors by 20%, I create systems that enhance both accuracy and efficiency. Cross-Functional Collaboration – I've partnered with globally distributed teams, vendors, and stakeholders to align quality objectives with business goals, negotiate quality agreements, and drive continuous improvement initiatives. Data-Driven Decision Making – I leverage quality metrics, trend analysis, and statistical tools to identify improvement opportunities and inform strategic decisions that strengthen organizational performance. My approach is straightforward: understand the regulatory landscape, identify gaps and risks, implement practical solutions, and continuously measure effectiveness. I believe quality isn't just a department—it's a culture that requires clear communication, collaborative problem-solving, and unwavering commitment to excellence. Let's connect if you're looking for someone who can bridge the gap between regulatory requirements and operational reality—someone who doesn't just maintain quality systems but continuously elevates them.

Multilingual Quality & Regulatory Consultant with 5+ years of experience ensuring compliance across highly regulated industries, including food, chemical, and medical products. Proven track record supporting QA implementation across supply chains, coordinating with cross-functional stakeholders, and developing technical content and training. Skilled in HACCP, PRPs, regulatory documentation, and supporting crisis/incident management. Passionate about operational excellence, continuous improvement, and fostering a strong quality culture across international teams. Fully trilingual in English, Spanish and German, with proven ability to navigate multicultural teams and markets.

Technical Consultant & Solutions Specialist Are you looking to bridge the gap between complex technical challenges and simple, scalable solutions? I help businesses, startups, and organizations turn raw ideas, operational bottlenecks, and data into efficient, real-world results. Whether you need strategic technical guidance, process optimization, or custom digital solutions, I focus on delivering practical systems that save time and drive measurable outcomes. Core Capabilities & Services * Technical Consulting & Solutions Architecture: Transforming technical requirements into clear, actionable roadmaps for implementation. * Process Automation & Workflow Optimization: Streamlining administrative and operational tasks using modern digital tools, custom scripting, and integrated software platforms. * Data Organization & Analytical Reporting: Structuring data pipelines, designing automated forms/dashboards, and turning raw data into clear, actionable business insights. * Curriculum & Training Framework Development: Designing structured technical training materials, interactive workshops, and STEM-focused educational content. Why Work With Me? * Problem-First Approach: I don't just execute tasks; I analyze the root problem to build solutions that scale with your needs. * Clear Communication: Complex technical concepts translated into clear, simple language so you always know where your project stands. * Efficiency-Driven: Focused on building self-sustaining, automated systems that keep your operations running smoothly. Ready to streamline your systems or bring your next project to life? Let’s connect and discuss how we can achieve your goals.

PROFESSIONAL PROFILE Dynamic, Innovative and versatile Leadership Professional with over twenty years fast paced culinary and hospitality management experience. Demonstrated success creative and effective menu development, plate presentation, menu costing, and price analysis. Strong leadership skills in directing fast paced large volume operational environment, team building, training and customer account management. Highly accomplished HACCP and FSMA Food safety operational performance operator. Demonstrated dedication to academics with recognized caliber in experience, creditability, collaboration, and creativity. Known by colleagues as an enthusiastic and passionate out-of-the-box thinker focused on quality, effective partnerships, community service, education, efficiency, and strategic priorities

Are you exporting food or personal care products and need expert support with FDA label reviews, INCI lists, HACCP plans, or compliance documentation? I’m Nazia, a Quality, Regulatory Affairs & R&D Consultant with over 12 years of experience working across the food and cosmetics industries. I’ve led QA, compliance, and R&D for FSSC 22000-certified food manufacturers and GMP-compliant cosmetic facilities, and now offer regulatory consulting for brands targeting the U.S., EU, UK, and Australia. What I Can Help You With FDA/EFSA/FSMA label reviews (21 CFR 101, 111, etc.) INCI list creation and cosmetic compliance documentation (EU/US/AICIS) HACCP plans and hazard analysis for food and supplement products COA, product specifications, and shelf-life studies Audit readiness, GFSI/BRCGS documentation, and supplier approval support Why Work With Me 12+ years in regulatory compliance, quality systems, and lab leadership Strong working knowledge of Codex, FDA, EFSA, BRCGS, AICIS, and ISO standards Balanced scientific and practical approach to get you export-ready Whether you’re launching your first product or expanding internationally, I’ll help you navigate the regulations and prepare high-quality, inspection-ready documentation. Message me today to discuss your compliance project or documentation needs.

I am a food and dietary supplement regulatory consultant with over 12 years of industry experience, including regulatory and quality assurance roles at Unilever. I currently serve as a compliance consultant for food companies in Australia and Canada, alongside project work for brands and importers worldwide. I hold an MS in Food Science and Technology, am an FSSC 22000 Certified Lead Auditor, and am FSPCA certified in Foreign Supplier Verification Programs (FSVP). I advise brands and importers on compliance in the United States (FDA), Canada (CFIA), Australia and New Zealand (FSANZ), the United Kingdom, and the European Union. Areas of practice: Label and claims compliance: Review of Nutrition Facts and Supplement Facts panels, ingredient statements, allergen declarations, and health, structure/function, and nutrient content claims under 21 CFR 101, as well as CFIA, FSANZ, UK, and EU labelling requirements. Deliverable: a written compliance report identifying each issue, the applicable regulation, and the required correction. Amazon compliance: Label reviews and compliance documentation for food and supplement listings, including reinstatement of suppressed listings. FSVP: Development of Foreign Supplier Verification Programs for US importers under FSMA, including supplier evaluations, hazard analyses, and verification procedures, with ongoing program maintenance available. Food safety systems: HACCP plans, hazard analyses, and risk assessments; GMP compliance for food (21 CFR 117) and dietary supplements (21 CFR 111). Certification preparation: Gap assessments, documentation, and internal audits for FSSC 22000, SQF, BRCGS, and ISO 22000. All engagements begin with a review of your product, label, or current documentation, after which I provide a defined scope, timeline, and fixed fee before any work begins.