Avinash K A.

Regulatory Affairs consultant for Health Canada and US FDA market entry. I prepare submission-ready applications, compliance reviews and label assessments for medical devices, natural health products, OTC drugs, dietary supplements, foods and cosmetics. As Principal of Arora 297 Consultancy (Kitchener, Ontario), I work directly with manufacturers, importers and distributors from Canada, the US, the EU and Asia. You deal with me throughout, not a junior team member. Health Canada • Medical Devices: Class I–IV classification, MDL applications, MDEL applications and inspection readiness, CAPA and SOP development • Natural Health Products: NPN product licence applications (Class I–III), NHP site licences, import/QAP support, label compliance • Food and supplemented foods: FDR/SFCR label reviews, Nutrition Facts table, bilingual labelling • Cosmetics: Cosmetic Notification Forms, ingredient hotlist screening, label review • Biocides and disinfectants: application support and labelling responses US FDA • OTC drugs: monograph compliance, Drug Facts labels, establishment registration, NDC/labeler code, US Agent services • Dietary supplements: Supplement Facts labels, structure/function claims, FDA registration • Medical devices: classification, establishment registration and listing, 510(k) strategy • eCTD submission preparation Quality systems: ISO 13485:2016 and MDSAP documentation, SOPs, and support through audits by the certification body. Why clients hire me • Precise, regulation-cited deliverables that are ready to submit • I anticipate the requests regulators are likely to send and handle them before they arrive • Clear fixed-fee quotes and fast turnaround Send me your product details and target market, and I'll reply with a regulatory pathway and a quote within 24 hours.