FDA & Health Canada Compliance Experts

Navigate FDA & Health Canada Regulations with Confidence

We guide medical device, cosmetics, OTC drug, and logistics companies through every stage of U.S. and Canadian regulatory compliance — from strategy to market clearance.

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15+

Years Experience

200+

FDA Submissions

100+

Global Clients

98%

Success Rate

Our Regulatory Services

Comprehensive FDA and Health Canada compliance solutions tailored to your product category.

Medical Devices

510(k) and De Novo submissions, UDI compliance, Health Canada MDL/MDEL, and Quality Management Systems.

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Cosmetics

MoCRA facility registration, product listing, labeling compliance, Health Canada CNF, and ingredient review.

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OTC Drugs

OTC monograph compliance, Drug Facts labeling, cGMP audits, and establishment registration.

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Regulatory Logistics

FDA Initial Importer programs, Prior Notice filing, import alert resolution, and FDA-registered warehousing.

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Our 5-Step Process

A proven methodology that takes you from initial consultation to market clearance.

Discovery

We assess your product, target markets, and regulatory pathway requirements.

Strategy

Custom regulatory roadmap with timelines, milestones, and cost projections.

Submission

We prepare and file all documentation with FDA and/or Health Canada.

Review

We manage agency communications and respond to any deficiency letters.

Clearance

Market authorization achieved. We support post-market compliance ongoing.

Years of Experience

FDA Submissions Filed

Clients Worldwide

Success Rate

Trusted By

Our Major Customers

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Logistics

FDA Certificate to Foreign Government (CFG): How It Opens Doors to Global Markets

Everything exporters need to know about FDA's Certificate to Foreign Government program — what it is, which certificate types exist, how to apply, and how CFGs help U.S. companies sell FDA-regulated products worldwide.

5/12/20258 min

Logistics

FDA Initial Importer Requirements: What Every Importer of FDA-Regulated Products Must Know

A complete guide to FDA Initial Importer obligations for medical devices, drugs, and food products — covering registration, labeling, recordkeeping, adverse event reporting, and import entry procedures.

4/8/20259 min

Food & Supplements

How to Get a Health Canada Natural Health Product (NHP) Licence

A step-by-step guide to obtaining a Natural Product Number (NPN) from Health Canada — covering product licence applications, site licences, evidence requirements, and labeling standards.

3/5/20258 min

Ready to Navigate FDA & Health Canada Compliance?

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