Health Canada & U.S. FDA Regulatory Consulting
Practical, defensible regulatory guidance for medical devices, natural health products, cosmetics, and food companies navigating complex compliance requirements.
Over 20 years of regulatory and compliance leadership supporting Canadian and international businesses.
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Confidential • No obligation • Senior-level guidance
Regulatory Guidance You Can Trust
Learn who we are, how we work, and how we help companies navigate FDA and Health Canada compliance with practical, defensible strategies.
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We offer the following solutions
Expert Regulatory Consulting for Health Canada & FDA Compliance
Medical Device
We provide end-to-end regulatory consulting services for medical devices, including 510(k) submissions, Health Canada MDEL and MDL applications, device classification, IVDR/IVDD transition support, labeling compliance, and ISO 13485:2016/MDSAP Audit ready services.
U.S. Agent & Legal Representation in Canada
At fraction of cost we can represent your company in the U.S.A and Canada. We have made it easy for you. Drop us an email or call us
Natural Health Products (NHP) Canada
We provide end-to-end regulatory consulting services for Natural Health Products (NHPs), including product licence applications (NPNs), site licence support, SOP development, GMP readiness and audit support, formulation review, and label compliance. With a proven track record of over 1,000 successful submissions and a success rate exceeding 90%, we help clients navigate Health Canada requirements efficiently. A complimentary regulatory gap analysis is available upon request.
Disinfectants & Biocides
We provide end-to-end regulatory consulting services for disinfectants and biocidal products, including DIN submissions in Canada, EPA registrations in the United States. Our expertise covers hand sanitizers, disinfectant sprays, and disinfectant wipes. Contact us for expert guidance across North American regulatory pathways.
Cosmetics USA | Health Canada | Europe
We provide full assistance with ingredient compliance, notifications, registrations, claims, and labelling. Are your cosmetic ingredients acceptable by Health Canada standards? Have you checked for VOC and California Prop 65? Have you checked for allergens ingredient (fragrance) for EU?
Veterinary Health Products (VHPs)
We provide regulatory consulting services for Veterinary Health Products (VHPs) in Canada, supporting compliance with Health Canada’s Veterinary Health Products Program. Our services include product classification, notification support, formulation and ingredient review, label compliance, and regulatory strategy for compliant market entry.
Food & Supplements
We support with SFCR Licence, Label Compliance, prepare Nutrition Facts table, Ingredient & allergen checks, Notifications to CFIA, registration of facilities (Foreign and Domestic), Import & Export issues, Novel food submissions, New ingredient submissions and more
Regulatory Intelligence & Updates
All new regulatory updates, changes, notifications, new policies
We believe in mutual growth
UNPARALLELED CONSULTING & REGULATORY SERVICES
Arora 297 Consultancy delivers expert regulatory consulting across the U.S., Canada, UK, EU, and Australia, supporting compliant market entry for medical devices, pharmaceuticals, cosmetics, diagnostics, food, and Natural Health Products.
- > SKUsCosmetic ingredient and label compliance
- > Happy Clients
- NHP > NHPs Product License
More than20years of industry experience
RELY ON OUR EXPERTS FOR REGULATORY MATTERS
Being active in the industry from the past two decades, we are aware of its complexities and challenges. We assist you to find the best possible solution for your problem keeping in mind the legalities and ever changing regulatory requirements.
Navigating global regulatory landscapes can be complex and resource-intensive. We make it clear, structured, and achievable.
We Arora 297 Consultancy partners with companies seeking compliant market entry and sustainable growth in Canada, the United States, and other key global markets. Led by Avinash K Arora, our experienced regulatory consultants provide strategic, end-to-end support—spanning regulatory submissions, classification and pathway strategy, compliance management, labeling and communications, and ongoing regulatory oversight. We manage regulatory complexity so you can focus on building, scaling, and growing your business with confidence
Regulatory Strategy
We, at Arora 297 Consultancy, look to grow our business associations into long-term relationships. We assist you to plan, strategize and execute strategies that are designed by skilled professionals who maintain a connection with you at all times, starting from assessments, registration, trials, licensing and quality assurance for fruitful outcomes.
Pre-submission
For seamless and hassle-free execution, we offer pre-submission services like data generation, regulatory and compliance with a gap analysis. While the data generation and review is done in accordance with formulations and ingredients checks, the expert reports help in facilitating successful registration.
Submission & Approvals
For carrying out successful submission, we provide services like Dossier review and submission along with technical documentation and administrative documents. Additionally, we also take care of dossier registration and submission to different authorities and query response management.
Post Approval
We try to be in touch with our clients for post-approval changes helping them to upgrade products with additional data as per country norms. We provide regulatory intelligence support in addition to planning, preparing and submitting fresh documents to the authorities.
GLOBAL REGULATORY SERVICES
Entering into the vast realm of medical and healthcare products in international markets of Canada, UK, EU, USA and Australia, requires a comprehensive understanding of complicated regulatory requirements.
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01Strategy Planning
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02Pre Submission
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03Submission/Registration
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04Post Submission/Approval
Regulatory Submissions
NHPs, DIN, Medical Devices, EPA, Food, New Dietary Ingredients, Cosmetics
Quality and Compliances
GMP, Quality Management System, Site License, Audits
Markets
Canada, U.S.A, India, UK, EU & Australia
Why Clients Choose Arora 297 Consultancy
Regulatory clarity. Reduced risk. Faster approvals.
Deep Regulatory Expertise
Over 20 years of hands-on experience across Health Canada, US FDA, EU, UK, and global regulatory frameworks.
End-to-End Ownership
From regulatory strategy and gap analysis to submissions, approvals, and post-market compliance.
Risk-First Approach
Every project is structured to minimize regulatory risk, avoid rework, and withstand audits.
Direct Senior Access
Clients work directly with senior regulatory professionals — no junior handoffs, no outsourcing.
20+ Years Experience
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Global Regulatory Coverage
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Health Canada & FDA Focus
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Audit-Ready Submissions
Regulatory Insights
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