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. |