A USA-based biopharmaceutical company was searching for a proven Regulatory partner to file NDA LCM submission in eCTD and promotional labeling, including conversion of documents into the eCTD as required by the US FDA. The client was aiming for a high-quality submission within rapid delivery timelines.

Download the proven case to find out how Freyr provided Regulatory support by delivering end-to-end Regulatory services to ensure valid NDA LCM submission with zero errors and warnings.