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Regulatory environments don’t exist in isolation — neither should your compliance architecture. I help organizations navigate overlapping legal systems and AI-driven operational models through comparative regulatory analysis and structured risk mapping. The Comparative Advantage As a jurist with a Master’s in International & European Law, my expertise is defined by method, not by one statute. I analyze how regulatory frameworks intersect, where obligations converge or conflict, and how those tensions translate into operational exposure. My methodology converts legal complexity into structured risk matrices designed for: • Multi-Market Operations: Aligning compliance across jurisdictions while reducing redundancy and regulatory friction. • AI & Digital Innovation: Identifying exposure in AI-driven systems, data workflows, and copyright-sensitive environments. • Structural Risk Audits: Conducting large-scale gap analyses to detect systemic vulnerabilities before they escalate. Precision & Execution Strategic analysis must translate into operational clarity. I ensure compliance is reflected in every layer of documentation and implementation: • Cross-border contract review and DPA structuring • Policy drafting and decision-ready regulatory briefs • Technical legal proofreading in bilingual (English/French) regulatory environments • AI data integrity verification supporting legally sensitive workflows Selected Impact • Audited 200+ digital applications using a replicable comparative compliance framework • Delivered cross-border DPA harmonization and regulatory gap assessments • Designed end-to-end compliance modernization frameworks for digital communications and AI-enabled operations I don’t deliver abstract legal commentary — I provide structured regulatory roadmaps that decision-makers can act on with confidence.

As a Healthcare and Nutrition Manager, I specialize in project management, data entry, and content development for my organization. I offer expertise in project management, assisting with data entry, and providing writing and proofreading services for ideas and content. Leveraging my management and leadership skills, I can effectively oversee your social media content or manage any aspect of your business that requires strong leadership and organizational oversight. Key Responsibilities: - Strategic Planning & Leadership - Develop organizational goals and objectives. - Plan and implement policies and procedures. - Lead departments and staff effectively. - Budgeting and Financial Management - Prepare and manage budgets. - Monitor spending and ensure financial sustainability. - Analyze cost-effectiveness and optimize resource allocation. Staff Management: - Hire, train, and evaluate staff performance. - Manage schedules and staff development. - Ensure appropriate staffing levels. Regulatory Compliance & Quality Assurance: - Ensure compliance with healthcare regulations (HIPAA, OSHA, etc.). - Maintain accreditation standards (e.g., Joint Commission). - Monitor and improve patient care quality and safety. Patient Care Coordination: - Facilitate efficient patient services and workflows. - Address patient concerns and complaints. - Oversee patient records and privacy protocols. Communication & Public Relations: - Serve as liaison between departments, patients, and external stakeholders. - Communicate policy changes and updates. - Handle media and community relations when necessary. Technology & Information Management: - Implement and manage health information systems. - Oversee data privacy and security protocols.

ABOUT ME Regulatory documentation that holds up under Notified Body and health authority scrutiny — that's the standard I work to. I'm a RAC-Drugs (Global) and ICH-GCP certified Regulatory Affairs Consultant and Medical Writer with 4+ years of direct, senior-level execution across pharmaceutical, biologic, medical device, IVD, SaMD, vaccine, combination product, cosmetic, and dietary supplement programs spanning FDA, EMA, Health Canada, CDSCO, TGA, PMDA, MHRA, SwissMedic, and GCC regulatory frameworks. Strong science doesn't move submissions forward on its own. What moves them is documentation that's technically accurate, strategically positioned, and built to how health authorities actually evaluate safety, efficacy, quality, and compliance. That's where I add value — especially when a submission has already been refused, rejected, or flagged. SUBMISSION REMEDIATION & REGULATORY CRISIS RESPONSE 20+ regulatory refusal, inspection, and non-compliance response cases across seven health authorities: — FDA: 8–10 Form 483 responses; 4 ANDA RTR; 4 RTF (3 NDAs, 1 BLA/biologic); 2 RTA (510(k) device, De Novo drug) — FDA ODD: Remediated a rejected dual-indication ODD for a rare CNS condition — strategic repositioning and evidence restructuring to achieve submission readiness — Health Canada: Inspection Exit Notice + Report of Findings — EU: 6 Statements of Non-Compliance — TGA: 2 GMP Inspection Report responses — SwissMedic: Inspection Report (Non-Conformities/Deficiencies) — MHRA: Inspection Report (Critical, Major, and Other deficiency classifications) CLINICAL EVALUATION & SYSTEMATIC LITERATURE REVIEW — EU MDR/IVDR Authored CER literature reviews and SOTA sections for 5 regulated products across 3 device classifications — including 2 solo-authored SLRs — all Notified Body or Health Canada reviewed. Scope: Class IIa active physiological monitoring devices (EU MDR 2017/745, Rule 10); Class B self-test IVDs (EU IVDR 2017/746, Rule 4); Class C diagnostic IVDs (EU IVDR 2017/746, Rule 4); Health Canada Class II. PRISMA-documented searches across PubMed/MEDLINE, Embase, Cochrane — aligned to MEDDEV 2.7/1 Rev 4, MDCG 2020-6, MDR Annex XIV. CORE SERVICES — Submission remediation: FDA 483, RTF/RTR/RTA, ODD, Statements of Non-Compliance, GMP inspection reports — FDA, EMA, HC, TGA, MHRA, SwissMedic — CER, PER, SLR, SOTA — EU MDR/IVDR, Health Canada — IND/CTA/NDA/ANDA/BLA documentation (Modules 2–5), eCTD publishing — Clinical writing: protocols, IBs, CSRs, safety summaries — Global labeling: USPI, SmPC, Canada PM, Australia PI, Japan IF — Combination products: inhalers, auto-injectors, drug-device combinations — Cosmetics: MoCRA, CPNP, UK CPSR, TGA, Health Canada SOR/2016-169 — Dietary supplements: FDA DSHEA, EU notifications (5 member states) — Health Canada MDEL/MDL, therapeutic claim reclassification — Regulatory strategy, gap assessments, SOPs, CAPA TRACK RECORD — 20+ refusal and inspection cases — FDA, EMA, HC, TGA, MHRA, SwissMedic — including BLA RTF, De Novo RTA, rejected ODD remediation for rare CNS dual-indication — 5 CER/SLR projects across EU MDR and EU IVDR — all NB or HC reviewed — Dietary supplement notifications across 5 EU member states + FDA DSHEA — HC MDEL/MDL for consumer product reclassified as Class II medical device — MoCRA cosmetic cross-regional (TGA + MHRA CPSR); CPNP + HC SOR/2016-169 — 4 TGA drug submissions, 2 TGA device submissions, black box labeling — EpiPen cross-regional program: FDA, EMA, MHRA, TGA — filing through global expansion — Combination products: inhalers, insulin pen, biologic-coated orthopedic implant — FDA, EMA, TGA, PMDA, HC, GCC — GCC registrations: UAE, KSA, Oman, Bahrain, Qatar, Kuwait WHY CLIENTS HIRE ME — RAC-Drugs (Global) and ICH-GCP certified — validated, not self-declared — Top Rated Plus, 100% Job Success Score, $40K+ delivered across 13 projects — Direct senior-level execution — no juniors, no handoffs — Responsive delivery on fast-moving timelines — including crisis timelines If you need regulatory documentation and submission strategy that health authorities actually approve — or remediation when they don't — let's talk about your project.

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

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

Hi, I’m Shreya Zope — a Certified Food Safety & Regulatory Compliance Expert with 7+ years of experience helping exporters, importers, manufacturers, and warehouses in Canada and the U.S. stay compliant, audit-ready, and efficient. I combine my biotechnology background with graduate certificates in Food Safety & Quality (Conestoga College) and Supply Chain Management (Humber College) — along with advanced certifications including: ✅ SFCR (Canada) – Safe Food for Canadians Regulations ✅ PCQI – FSPCA – Preventive Controls Qualified Individual ✅ HACCP Level 4 Certified ✅ ISO 9001:2015 Internal Auditor ✅ BRCGS Internal Auditor My approach is practical, fast, and regulatory-accurate, designed to help food businesses achieve compliance with confidence. My Expertise Includes: 1) CFIA & FDA Food Label and Packaging Compliance Reviews 2) Custom SOP Templates for warehouses, manufacturers, and distributors 3) Import/Export Documentation Review for U.S. & Canadian markets 4) Food Safety Audits (HACCP, GMP, ISO 9001 readiness) 5) Internal Audits and QMS Implementation 6) Team Training on GMP, GLP, HACCP Standards I’ve helped CPG brands, breweries, logistics providers, and manufacturers: 1️⃣ Ensure products meet CFIA/FDA standards to avoid costly delays 2️⃣ Implement standardized quality systems and SOPs 3️⃣ Build preventive control plans and maintain audit readiness 4️⃣ Streamline supply chain operations while staying fully compliant Whether you’re preparing for certification, expanding into a new market, or simply want peace of mind with your documentation, I’ll help you simplify compliance and protect your business reputation. 📌 Let’s work together to make your food operations safe, compliant, and audit-ready — so you can focus on growth.