The article outlines the challenges faced by a biopharmaceutical company during its New Drug Application (NDA) submission, including overcoming trial master file issues, staff turnover, and the complexities of a resubmission after a regulatory setback. It highlights the role of a strategic partnership with service providers in navigating these obstacles and ensuring a successful resubmission. The article underscores the importance of comprehensive support in managing the intricacies of the NDA process.
