Case Study: Global Regulatory Intelligence for Dental Brand



Client:

A global dental care brand headquartered in the United States.


Problem Statement:

The Client had portfolio of dental care cosmetic products that it intended to register and launch in 21 countries worldwide. Client required a strategy based on country specific regulatory requirements for cosmetic products/dental care products to formulate a global product roll out strategy. Client did not have presence outside the United States and had limited experience in other markets.


Stakeholders:

Various stakeholders from Regulatory Affairs, Marketing, Sales and Leadership team were involved


Artixio's Solution:

Artixio's Cosmetic Consulting team was formulated including the regional regulatory experts from countries of target. Led by the project manager, a solution was developed that included 360 degree assessment of the market landscape to enable decisions for go to market. The assessment included,

  • Analysis of regulatory pathway for registration of cosmetic/dental care products in target countries

  • Ingredients safety assessment and permissible limits in those countries

  • Review of label compliance in those countries

  • Documentation required for registration

  • Timeline and Health Authority Fees

  • GMP requirements

Further, additional parameters such as fast track process based on previous approvals in United States were assessed in respective countries.


Based on the above assessment a matrix was developed highlighting the priority markets based on Client's readiness, ease of registration, timelines and cost. This matrix was compared with priority markets identified by the marketing team and availability of distributors in those countries to finalize the target market list and launch strategy.


Timelines:

The entire activity was completed in 8 weeks followed by a strategic workshop


Key Outcomes:

Client's team was able to make informed decision and develop commercial product launch roadmap in countries around the world based on the priorities recommended by Artixio. The recommendations were driven by Regulatory Intelligence.


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