Post-approval compliance in the US and Canada requires robust pharmacovigilance, quality management, regulatory lifecycle oversight, and adherence to FDA and Health Canada rules to maintain market access.
This guide details preparing regulatory files for medical devices, cosmetics, and pharmaceuticals, emphasizing compliance with FDA and Health Canada standards, proper formatting, and benefits of expert consultancy.
This guide outlines how to avoid US FDA and Health Canada approval delays by thorough submission planning, quality readiness, agency engagement, and partnering with Arora 297 Consultancy for expert regulatory…
Health Canada's new fragrance allergen disclosure rules took effect April 12, 2026. Here's what changed for your CNF filing and product labels — and what to do now. If your…
If you want to sell vitamins, herbal products, probiotics, or any natural health product in Canada, you need a Natural Product Number (NPN) — a licence issued by Health Canada…
Securing OTC drug compliance Canada & USA necessitates rigorous adherence to evolving regulatory frameworks. Quality Assurance Managers, Product Managers, and Regulatory Specialists face mounting pressure to align product portfolios with…
This playbook guides creating compliant FDA and Health Canada regulatory files by detailing dossier components, addressing deficiencies, strategic planning, labeling compliance, GMP/ISO standards, and eCTD submission for faster approvals.
Regulatory intelligence enables proactive, risk-based compliance by monitoring FDA and Health Canada updates, integrating with quality systems, and supporting strategic submissions. Arora 297 offers tailored consulting and free assessments in…
Regulated product launch delays often stem from regulatory oversights, submission challenges, and quality issues. Structured project management, robust QMS, proactive communication, and expert consultancy like Arora 297 mitigate risks and…
Accurate label and ingredient reviews are vital for cosmetic compliance under FDA MoCRA and Health Canada rules. Arora 297 Consultancy offers expert support to ensure regulatory adherence, avoid risks, and…
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