SPL Editor™

Introducing SPL Editor: The New Standard

As of Fall 2005 the FDA required that the labeling content in regulatory submissions be submitted in SPL (Structured Product Labeling) format. The benefit of SPL implementation is that the transfer of information separates the document content from its format. This separation enables content to be shared through differing computer systems. SPL aims to facilitate communication amongst drug developers, product manufacturers, regulatory reviewers, and direct consumers. The concern, however, is the impact of this new technology standard on current business practices. SPL Editor provides the technical capabilities for SPL generation without requiring major changes to current successful business practices.

• SPL Editor Features:
• System generates XML Header
• Add Text: Main Sections and Sub-Sections
• Create valid lists: Bulleted and Numbered
• Use Special Characters
• Insert Images: JPEG and GIF files
• Build Tables in Valid SPL Format with: - Titles - Headers- Content - Footnotes
• Form based Drug Data Listing entry
• Preview your Output
• Built in SPL validation tool
• Publish valid SPL Documents

Professional SPL Conversion Services

In an effort to help clients meet their regulatory requirements, MedXview provides the service of converting current labeling content into the required SPL format. Our professional services team eliminates the need for you to hire and train additional personnel or implement and maintain software solutions. This approach allows you to focus on more pressing regulatory duties.

MedXview begins using your completed Microsoft Word Documents as source documents for SPL conversion. We can also create a new MS Word Document from archived/historical/printed labeling content. Clients receive notification of project completion and receive electronic copies of the valid SPL deliverables. These deliverables can then be sent directly to the FDA for proper review. Our consulting staff can also help to fill the gap, providing valuable SPL education for your team so that in time you can handle SPL creation in-house. Our clients have experienced the greatest return on investment when taking a dual approach, simultaneously taking advantage of our valuable software solutions and professional services.

The deadline for FDA mandatory filing of product labeling information in the SPL (Structured Product Labeling) format is rapidly approaching. Many pharmaceutical developers, therefore, have determined the need for a reliable service provider that will enable the company to meet regulatory compliance guidelines without straining current business practices. MedXview will conveniently utilize your current labeling content and transform this readily available content into the required SPL format.