Structured Product Labeling
DDReg’s Structured Product Labeling Services empower pharmaceutical, medical device, and biopharmaceutical organizations to achieve seamless compliance with regulatory standards. Our team of labeling experts ensures that product information is consistently formatted for efficient submissions and review.
DISCOVER MOREUnderstanding SPL and Regulatory Compliance
Structured Product Labeling (SPL) is a document markup standard approved by Health Level Seven (HL7) and adopted by the FDA for exchanging product and facility information. In 2005, the FDA released the “Providing Regulatory Submissions in Electronic Format — Content of Labeling” guidance, establishing the use of XML-based SPL for submitting labeling content in marketing applications such as NDAs, ANDAs, and BLAs.
This FDA-endorsed approach to labeling ensures that data is consistently structured and accurate. Regulatory bodies leverage this technology to efficiently manage labeling updates and changes, streamlining the review process and enhancing the integrity of regulatory submissions.
Our Expertise in SPL Submissions and Labeling Conversion
At DDReg, our team of highly qualified labeling professionals not only authors and develops package inserts and medication guides but also expertly converts these documents into XML-format SPL files. We maintain strict adherence to FDA guidelines, ensuring that every submission meets regulatory standards. Our support extends across healthcare, medical devices, and biopharmaceutical sectors, offering a comprehensive solution for validated SPL labeling.
We manage the entire SPL lifecycle with version-controlled processes that guarantee compliance with FDA requirements and specifications. By integrating our services into your regulatory strategy, you can expedite approvals and enhance the overall quality of your electronic submissions.
Our Structured Product Labeling Expertise
- Conversion of package inserts and medication guides into XML-based SPL files
- Implementation of FDA-compliant labeling processes
- Management of version-controlled SPL lifecycles
- Expertise in electronic submission formats for NDAs, ANDAs, and BLAs
- Support for healthcare, medical device, and biopharmaceutical organizations
Ready to streamline your labeling process and enhance your regulatory submissions?