About Arora 297 Consultancy

Senior-Led Regulatory Guidance for Health Canada and US FDA

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.

Who We Are

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.

By the Numbers

Two decades of regulatory practice across Canada and the United States.

20+Years Experience

1,000+Submissions Filed

100+Companies Supported

98%Audit Success Rate

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
Cross-border US–Canada market entry

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 AssessmentClassification, claims review and gap analysis.
Documentation & Label ReadinessEvidence alignment, bilingual compliance and packaging review.
Submissions & Market AccessHealth Canada and US FDA coordination.
Post-Market ComplianceChanges, complaints, recalls and ongoing obligations.

Our goal is simple: reduce uncertainty, avoid rework, and help you launch and scale with confidence.

Senior Leadership Team

Engagements are directed by senior practitioners, not layered account management structures.

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

Connect on LinkedIn →

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.

What We Offer

Over 20 years of regulatory and compliance experience across Canada and the United States.

Medical Devices

Health Canada MDEL & MDL support, US FDA establishment registration, product listing, 510(k) submissions, labelling compliance and post-market regulatory support.

Medical device services →

U.S. Agent & Canadian Representation

Acting as U.S. Agent and Canadian regulatory representative for foreign manufacturers, supporting cross-border compliance and ongoing regulatory obligations.

U.S. Agent services →

Natural Health Products

NPN submissions, site licensing, GMP readiness, IRN responses, DIN-NHP conversions and regulatory strategy for Health Canada compliance.

NHP services →

Drugs & OTC Products

Support for drug establishment licensing, DIN applications, structured product labelling and regulatory documentation preparation.

OTC drug services →

Cosmetics

Cosmetic notification (CNF), ingredient and safety assessments, labelling compliance and regulatory risk review for the Canadian market.

Cosmetic services →

Disinfectants & Antimicrobials

DIN applications for Canada and EPA registration support for the U.S., including regulatory strategy and submission coordination.

Biocide services →

Mission, Vision and Goal

Mission

To deliver clear, defensible regulatory solutions that reduce uncertainty, prevent costly delays and align compliance decisions with long-term business objectives.

Vision

Faster, better, smarter regulatory execution — built on over 20 years of compliance experience across Canada and the United States.

Goal

To become your regulatory department — the partner clients trust with their hardest decisions.

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 See Our Client Portfolio