The regulatory requirements for health products are constantly evolving. Knowing how your product might be affected by the latest changes—whether it’s on the shelf now or still under development—can be a challenging task for any company.
Ensuring regulatory compliance is essential to the success and growth of a brand. Companies that lack an in-depth understanding of the regulatory framework could be missing out on important market opportunities.
Our knowledgeable team will guide you through the regulations so you can gain market access quickly, successfully, and with confidence. To date, we have completed over 2,000 regulatory filings to Health Canada and the U.S. Food and Drug Administration (FDA) with a 97% success rate.
Explore our regulatory services:
GLOBAL MARKET ACCESS SOLUTIONS
- Compliance Consulting
- Health Claims Substantiation
- Scientific Literature Reviews
- Product Classification
- Nutrition Facts Panel Review
- Technical Label Review
- New Drug Submissions (NDS) and New Drug Applications (NDA)
- Abbreviated New Drug Submissions (ANDS) and Abbreviated New Drug Applications (ANDA)
CANADIAN MARKET ACCESS SOLUTIONS
- Natural Health Product (NHP) Licensing
- Temporary Marketing Authorization (TMA) Applications
- Master File Submissions
- Natural Health Product (NHP) Site Licensing
- Drug Establishment Licensing
GAIN U.S. MARKET ACCESS SOLUTIONS
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