Global Applications & Submissions
Helping Manufacturers Navigate Global Nicotine Product Regulatory Pathways
From consumer goods notifications under the UK’s Tobacco and Related Products Regulations (TRPR) or the EU’s Tobacco Products Directive (TPD), to medical applications to the UK Medicines and Healthcare Products Regulatory Agency (MHRA) or Australia’s Therapeutic Good Administration (TGA), we help organizations across the globe assess, plan and submit their regulatory filings.
Savvy nicotine application strategies that
get new products to market across the world.
To develop market-by-market strategies that address different requirements across different global regulators, which is one of the key challenges of navigating entry to diverse markets.
Our global team has experience across every global market, and can help you build a strategy that aligns with your business and budget.
A faster, more efficient journey to market with a group of professionals that works as an extension of, and in support of, your team.
Leverage our expertise to create and execute comprehensive global regulatory strategies.
Our Approach to Global Marketing Applications
While not the only pathways we help navigate, consumer goods applications in the EU and the UK, as well as prescription license applications in the UK and Australia, make up the majority of our work.
Ensure accurate collection of data related to emissions, nicotine dosing, packaging, ingredients, and labeling. When necessary, we can also design and implement clinical studies in support of submissions.
Work with manufacturers to ensure the products meet standard requirements related to nicotine strength, tamper resistance, labeling/marketing materials, and instructions for use.
Supporting an annual reporting framework to maintain compliance.
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