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FDA SPL - Structured Product Labeling
FDA SPL is a software that aids pharmaceutical companies and the repackaging/ re-labeling Industry to author SPL files needed to register with US Food and Drug Administration. The application allows easy document authoring by displaying SPL structured data in a comprehensive tree view.
The product label itself can be authored in Microsoft Word and then be loaded into the SPL document authored with FDA SPL application.
Alternatively SPL document sections as well as coded information such as products, ingredients, product characteristics etc. can be imported from existing SPL files e.g. from those available on the Daily Med website.
All Dictionaries required by the Food and Drug Administration for correct SPL coding and submission are integrated and can be easily accessed. The Application allows full text search with wildcards in the installed dictionaries such as LOINC, UNII Codes and NCI Thesaurus.
Data manageable with the application:
Establishments such as Manufacturers, US Agents, Importers, Relabel etc.
Trade Name, Generic Name of the Product(s)
Company Information and Legal Authenticators
Label Version, Revision, First Approval, Marketing Status and Information.
Product Indications
Preconditions such as Co-Administration, Patient Age and Maximum Dose
Contraindications
Ingredients and Eccipients (Inactive Ingredients)
Drug Interactions
Adverse Reactions
Product Properties such as color, shape, image etc.
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