[[ p3 ]]Global regulatory strategy and submission, for both trade and nonproprietary names, are critical to gaining global brand approval. At Leaderboard, our experts provide guidance on the best regulatory strategy and submission for your asset based on desired markets and development timelines.

[[ p3 ]]There are several different strategies that should be taken into consideration when creating name candidates and filing trade names to regulatory health authorities. As a part of our trade name development process, name candidates are always thoroughly screened from both a legal, regulatory and drug safety perspective to ensure there are no major conflicts. We assess and adjust our process to stay current to published guidance from global health authorities.

[[ p3 ]]Leaderboard works with the client regulatory team to determine the most effective strategy for application submission for USAN and INN. Drug safety experts provide recommendations on the asset’s stem and assist with any communications to regulatory agencies. Leaderboard supplies a report with the evaluation process that was performed on the top name candidates and can submit the regulatory applications.

[[ p3 ]]Preparing Trade Name White Papers to support the name applications to the FDA, EMA, MHRA and Health Canada for your asset is essential for the name candidates journey. The documents will be written for the top name and will include the roadmap of how the name was created, evaluated, tested and selected. Leaderboard provides ongoing regulatory consultation to when name submission applications are under review of the regulatory health authorities.

[[ p3 ]]Conducting an in-depth review of the health agency message detailing the name rejection assesses the grounds for rejection and informs the framework for counter arguments that address all points of concern raised in the objections. After a full analysis of potential differentiators, Leaderboard will develop the counter arguments that will be used to challenge the objections for trade names, nonproprietary names and or trademarks cited by the regulatory agency.

[[ p3 ]]While developing package and label designs globally, applying Med-E.R.R.S. expertise to mitigate risk and stand out among competitors is driven by guidance published by the FDA, EMA, PMDA, Health Canada, MHRA, and each respective regulating body around the world. A comprehensive review is then conducted to ensure all regulatory requirements have been met.