Who We Are
About Arora 297 Consultancy
Strategic regulatory guidance with practical execution—led by senior regulatory leadership with over 20 years of hands-on experience across Health Canada and U.S. FDA frameworks.
At Arora 297 Consultancy, we help businesses navigate complex regulatory environments with clarity, confidence, and purpose. We don’t offer vague advice or generic checklists. We translate regulations into actionable steps that reduce risk, prevent delays, and support sustainable business growth.
Our work spans medical devices, natural health products, cosmetics, food, and OTC products—supporting both Canadian and international market entry.
Practical Solutions
Clear guidance, defined timelines, and execution-ready deliverables—no regulatory guesswork.
Strategic Thinking
Regulatory decisions aligned with commercial goals, future expansion, and long-term compliance.
Defensible Compliance
Risk-based decisions grounded in legislation, guidance, and real enforcement experience.
Who We Work With
We support startups, growing businesses, and international manufacturers that require reliable regulatory direction for regulated products, including:
- Medical Devices (Health Canada & US FDA)
- Natural Health Products (NPNs, site licensing, GMP readiness)
- Cosmetics (label compliance and CNF support)
- Food & Supplements (label and claims readiness)
- Import / export and regulatory representation
How We Work
Most regulatory delays occur because compliance is addressed too late or handled in fragments. Our approach is structured, proactive, and execution-focused:
- Regulatory Pathway & Risk Assessment – classification, claims review, and gap analysis
- Documentation & Label Readiness – evidence alignment, bilingual compliance, packaging review
- Submissions & Market Access – Health Canada and US FDA coordination
- Post-Market Compliance – changes, complaints, recalls, and ongoing obligations
Our goal is simple: reduce uncertainty, avoid rework, and help you launch and scale with confidence.
Senior Leadership Team
Avinash K Arora, BSc Pharm, MBA, RAP
Founder & Principal Consultant
Avinash brings over two decades of regulatory and compliance leadership across pharmaceuticals, medical devices, natural health products, cosmetics, and food compliance. His experience spans the full product lifecycle—from early-stage regulatory pathway design to post-market compliance—allowing him to anticipate risks before they become obstacles. Over the years, he has advised startups, growing enterprises, and established organizations on navigating Health Canada and US FDA requirements with precision and pragmatism.
Avinash is recognized for translating complex regulatory expectations into clear, defensible strategies that support sound business decisions, reduce regulatory uncertainty, and enable sustainable market access.
- Health Canada & US FDA regulatory strategy
- Label and claims defensibility
- End-to-end submissions and post-market compliance
- Quality systems and SOP framework development
Abul Ansari
Senior Leadership Team | U.S. Regulatory Lead
Abul Ansari brings extensive experience in U.S. regulatory affairs, quality systems, and compliance across regulated health and consumer product sectors. As the U.S. Regulatory Lead for Arora 297 Consultancy, he provides strategic oversight and practical guidance on U.S. FDA regulatory pathways, compliance planning, and execution.
He supports clients with regulatory strategy development, documentation readiness, quality and compliance alignment, and cross-border market entry—helping reduce risk and ensure defensible decisions for long-term success in the U.S. market.
Our Current Team
Krunal Upadhyay
Regulatory Affairs Specialist – NHP
Krunal brings over 8 years of pharmaceutical industry experience from his tenure at Sun Pharma. He holds a Bachelor’s and Master’s degree in Pharmacy and has completed a Post-Graduate Certificate in Regulatory Affairs from Conestoga College.
At Arora 297 Consultancy, Krunal supports regulatory projects, dossier preparation, and compliance initiatives across NHP, OTC, medical device, cosmetics, and food regulatory landscapes.
Christine Thou
Regulatory & Compliance Specialist – Medical Devices
Christine has experience supporting medical device companies in regulatory and quality assurance activities, including quality systems, technical documentation, post-market surveillance, audit preparation, and gap analyses.
She has worked with ISO 13485, MDSAP, and Health Canada requirements and has contributed to the development and maintenance of technical documentation, risk management files, and quality system records. Christine is committed to clarity, accuracy, and continuous improvement, and focuses on practical regulatory solutions that support operational efficiency.
Start with Clarity
If you are preparing a product launch or facing regulatory uncertainty, let’s map the most efficient and defensible path forward.
Book a Strategy Call
