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Need an experienced Regulatory and Food Safety Consultant to help bring your product to market, strengthen your food safety systems, or navigate complex global food regulations? You're in the right place. With 17+ years of experience in Food Regulatory Affairs, Quality Assurance, Food Safety, Product Development, and Nutrition, I help food manufacturers, ingredient suppliers, startups, and consultants solve complex technical and regulatory challenges. Food Regulatory Compliance I help businesses understand and comply with food regulations across multiple markets, including the USA, Canada, European Union, Australia, New Zealand, India, and other international jurisdictions. Services include: -Ingredient and additive compliance assessments -Regulatory research and interpretation -Product and formulation reviews -Label compliance reviews -Market entry and regulatory guidance Food Safety & Quality Assurance I develop practical food safety and quality systems that keep your business audit-ready and compliant. -I can support you with: -SOPs, GMPs and prerequisite programs -HACCP, FSSC 22000 and SQF documentation -Internal audit preparation -Gap assessments and corrective action plans -Specifications and document management Nutrition & Scientific Research As a qualified Food Scientist with experience in R&D and product development, I combine scientific expertise with commercial insight. I can assist with: -Ingredient and product research -Nutrition and scientific content writing -Literature reviews -Food trend research Why work with me? ✔ 17+ years of industry experience ✔ Expertise across Regulatory Affairs, Food Safety, Quality Assurance, Product Development, and Nutrition ✔ Global regulatory knowledge (USA, Canada, EU, Australia, New Zealand, India, and more) ✔ Practical, business-focused solutions - not just regulatory theory ✔ Reliable communication, attention to detail, and on-time delivery I pride myself on delivering high-quality work that helps clients save time, reduce compliance risks, and confidently move their products to market.

Summary • A dedicated, flexible professional with excellent organizational and problem‐solving skills supported by over 7 years of regulatory law ( cosmetics, medical devices, NHP) clinical research experience. • Provided support on all aspects of the Quality Management System including Regulatory Inspection, Corporate and Self‐Inspections, Recall Management, Contractor Compliance, Product Release, Stability Management, Change Control, Deviations, CAPA and GMP training. • Expertise in Good Manufacturing Practices (GMPs), Good Pharmacovigilance Practices (GVP), Current GMP for Canadian drugs and Natural Health Products, cosmetic regulations (Health Canada &FDA) and Good Clinical Practice (GCP)for pharmaceuticals. Applied a risk‐based approach to implementing regulations for various pharmaceuticals, cosmetics, Medical device and Natural Health Product companies, providing thoughtful justification for recommendations/decisions. • Knowledgeable about Health Canada practices and regulations for medical devices, NHPs, DINs, OTC drugs and cosmetics. Attentive and demonstrated success in handling domestic and international regulatory needs for diverse regulated product launches. Provided regulatory advice and risk assessment for business development. Adept at managing regulatory documents from start to finish, including assessing audits, evaluating technical data and checking information accuracy. Have successfully managed and obtained MDEL, Site Licenses, DEL and ISO quality management systems approvals for many companies. • Expertise in Completing the source documents, case report forms, and data queries in a timely manner, accurately, and completely for clinical trial. • A strong understanding of Cosmetic Regulations, Hot-listed/Restricted ingredients, Cosmetic Notifications, Label review, Quality Management, Clinical trials, regulatory work and an ability to implement challenging goals, objectives, and practices. • Worked successfully in a team‐based environment, as well as independently. Strong people management skills and leadership skills including coaching, mentoring and employee development. Efficiently prioritized and juggled many different projects and tasks by delegating to associates. Study: Bachelor of Science with specialization in Chemistry. Master of Drug Development which covers Clinical trials, BA/BE trials, Pharmacovigilance activities, Pharmaceutical regulated work for NHP, Cosmetics and Drug products. Base on education and training able to write regulated document such as SOP, regulated reports, label review, formulation compliance, cosmetics notification. Also able to manage clinical studies based on my experience.

I help supplement brands take early concepts, existing formulas and manufacturing problems and turn them into products that are scientifically sound, commercially realistic and suitable for their intended market. I’m a biochemist with an MSc and studied at Wageningen University & Research in the Netherlands. My background combines biochemistry, chemistry, food science and more than 15 years of practical formulation and manufacturing experience. That scientific background affects how I approach formulation. I don’t only check whether an ingredient is popular or whether it fits on a label. I look at its mechanism, human evidence, effective dose, source material, standardization, bioavailability, safety, interactions and behaviour inside the finished dosage form. Most clients come to me with one of three things: an early product idea, a formula they are not completely confident in, or a manufacturer telling them the product needs to be changed before it can be produced. I can help with: * New supplement formulation and reformulation * Biochemical and clinical review of existing formulas * Health Canada NPN applications, amendments and reviewer responses * US FDA ingredient, claim, Supplement Facts and label reviews * Australian TGA formula, ingredient, dose, indication and evidence reviews * International formula screening for the EU/EEA, UK, India and Asian markets * Manufacturer-ready specifications and Bills of Materials * Ingredient standardization, potency, overage and yield calculations * Stability, preservation, solubility, flavour and texture problems * CMO screening, technical transfer and pilot-production support * Independent audits of manufacturer proposals, formulas and cost models I have worked on approximately 50 Health Canada NPN applications across Class I, II and III. This includes preparing applications, Finished Product Specifications, label text, evidence packages, amendments and responses to Health Canada questions. I also support products intended for the US dietary supplement market and Australian complementary medicine market. The FDA, Health Canada and TGA systems are not interchangeable. Australia generally treats supplements much more like medicines, with tighter controls around permitted ingredients, therapeutic indications, evidence, manufacturing and product listings. A formula that works in the US may not work in Canada, Australia, Europe or India without changes. I compare ingredient status, dose limits, claims, warnings, evidence and manufacturing requirements early so clients do not develop a product that later needs to be reformulated. For markets requiring a local sponsor, authorized representative or country-specific legal filing, I prepare the scientific and technical package and work alongside the appropriate local regulatory specialist. My biochemistry work can include: * Clinical literature and ingredient evidence reviews * Mechanism-of-action and biological pathway analysis * Safety, contraindication and interaction assessments * Extract-ratio, standardization and active-yield calculations * Bioavailability and pharmacokinetic reviews * Claim substantiation and evidence-gap analysis * Comparison of branded ingredients and delivery technologies I formulate capsules, tablets, powders, gummies, stick packs, oral pouches, functional beverages, liquid supplements and selected pet products. Each formula is built around the intended customer, market, dosage form, clinical evidence, regulatory pathway, cost target and what the manufacturer can realistically produce. When it provides a genuine advantage, I can also work with delivery technologies such as liposomal systems, emulsions, cyclodextrin complexes, phytosomes and microencapsulation. I do not add expensive technology simply because it sounds good in marketing. It needs to improve stability, absorption, taste or manufacturability. I also consult within Canadian cGMP manufacturing, so I understand what happens after a formula leaves the spreadsheet. I can identify problems involving raw-material sourcing, bulk density, powder flow, gummy payload, flavour masking, preservation, water activity, packaging and equipment limitations before they become expensive production problems. Depending on the project, my deliverables can include: * A manufacturer-ready formula and specification sheet * Ingredient and dosing rationale with supporting references * Regulatory, safety, stability, sensory and cost risk flags * Proposed claims, directions and required cautions * Finished Product Specifications and NPN supporting documents * Manufacturing instructions and pilot-run recommendations * CMO qualification and comparison documents * Support communicating with manufacturers, laboratories and suppliers I am fairly direct about what works and what does not. If a formula is underdosed, unnecessarily complicated, difficult to manufacture or unlikely to support its intended claims, I will explain the problem and give you

PROFESSIONAL SUMMARY With over two decades in the medical device sector, I am a seasoned Senior Medical Device Consultant offering comprehensive expertise in global marketing authorization, EU MDR compliance, and robust quality management systems. My specialization lies in ensuring medical device product compliance, spearheading both internal and external audits, implementing advanced risk management strategies, and guiding post-market procedures. My proficiency extends to the design and management of Unique Device Identifications (UDIs), and I possess a deep understanding of Software as a Medical Device (SaMD). Having hands-on experience with a spectrum of international regulatory frameworks, I am adept with guidelines from the FDA, EU MDR, MDSAP, MHRA, PMDA, JPAL, TGA, and ANVISA. My extensive knowledge also covers critical areas like distribution selection and liaison with local competent authorities. This ensures that the products not only meet global standards but also align with regional and local compliance requirements. In my consulting capacity, I've consistently been the trusted advisor to senior and executive management teams of my clientele. I provide strategic direction, clarity on compliance obligations, and navigate the ever-evolving landscape of medical device regulations. Furthermore, I offer companies' executive teams pointed direction on imperative action items and provide invaluable insights on managing relationships with distribution networks and local regulatory bodies. PROFESSIONAL SERIVCES 1. Global Marketing Authorization 2. Regulatory Compliance 3. Quality Management Systems (QMS) 4. Post-Market Surveillance (PMS) 5. UDIs Management 6. Clinical Evaluation 7. International Council for Harmonisation (ICH) 8. Medical Device Software (MDSW) & Software as a Medical Device (SaMD) 9. Data Protection Impact Assessment (DPIA) EDUCATION • BSI, AU - Management Systems Auditing, 2018 • BSI, ISO 13485:2016 Internal Auditor (TPECS), 2018 • BSI, MD - Medical Devices Quality Management Systems, 2018 • American Society for Quality, ASQ-Certified Six Sigma Green Belt, 2008 • Mohawk College, Mechanical Engineering, 2001-2004