Two Labs’ Compendia team is comprised of former First DataBank/Medi-Span employees, with more than 100 successful product submissions completed. Our team also has experience in creating new therapeutic classes and dosage forms, which can enhance preferred payer reimbursement and prescriber visibility.
Two Labs’ Compendia team ensures compendia submissions are accurate and appropriately submitted at the optimal time for expedited data rollout for:
- Product launch
- Lifecycle management
- Price change notifications
- NDC transitions
Additionally, our Compendia services:
- Provide a structured key compendia-centric document
- Recommend a therapeutic class — or even create a new therapeutic class
- Determine if a product requires reclassification
- Establish product differentiation
- Establish dialogue with the three major Compendia databases — First Databank, Medi-Span and Gold Standard Drug Database – Elsevier
- Submit information in advance of your product launch
- Complete basic and strategic new product submissions
- Complete FDA labeler code applications
We also include strategy development and analysis to determine if key differentiating factors make it appropriate for your product to be filed for a new therapeutic class. This creates significant downstream implications, enhancing preferred payer reimbursement and prescriber visibility.