Our regulatory staff has industry experience managing all aspects of product labeling for prescription and over-the-counter drug products as well as dietary supplements.
Drug Listing
- Submission of Labeler Code requests
- Submission of Establishment Registration
- Conversion of labeling to required SPL format for electronic submission for Rx and OTC products
- Submission of drug listing to FDA
Labeling Management
- Review of FDA website for changes to innovator labeling
- Develop content of labeling in partnership with clients
- Prepare labeling for submission
