Structured Product Labeling (SPL) HT9426-26-Q-E022

The Defense Health Agency is seeking a contractor to manage, process, and complete initial labeling and labeling changes in electronic structured product label document submissions to the FDA. The contractor will be required to demonstrate expertise in managing, processing, and validating XML-based electronic Structured Product Label (eSPL) submissions via the FDA Electronic Submission Gateway. The contractor will also be required to provide quality control and validation processes to ensure zero-error submissions and rapid resolution of any FDA portal rejections. Some key requirements of the contract include: • FDA ESG Gateway Expertise: The contractor must demonstrate detailed approach to managing, processing, and validating XML-based electronic Structured Product Label (eSPL) submission via the FDA Electronic Submission Gateway. • Quality Control & Validation: The contractor must provide specific tools and quality assurance processes used to ensure zero-error submissions and rapid resolution of any FDA portal rejections. • Workflow Management: The contractor must demonstrate how they track labeling changes, maintain version control, and communicate submission status to Government Stakeholders.