The industry-standard solution for labeling
and regulatory intelligence

Develop compelling product labeling, which includes ensuring that the trial design is compelling starting in Phase 2.

With DOC Label

  • Draft differentiated product labeling:
    • Examination prior precedence
  • Labeling Alignment
    • Upload CCDS, regional labels, draft labels, and other label documents of interest to compare against approved products.
    • Efficient and accurate gap analysis
  • Compare different versions of labels quickly and easily.
  • Save and follow searches w/ automated update notifications:
    • Competitor labels/indications of interest
  • Quickly export and compare labels of interest during in-house labeling meetings.

Without

  • Unable to identify and examine all products with prior precedence with 100% certainty
    • Prior to FDA filing
    • During PDUFA
  • Hire extensive consulting resources for label alignment projects. Costs upwards of $500,000 per year with no guarantee on accuracy or quality of comparisons.
  • Compare versions of labels manually (2-3 days)
  • Regularly check on DailyMed and FDA website for label updates, no automation.
  • View one label at a time using DailyMed, no ability to export side-by-side comparisons

DETAILED LABEL ANALYSIS: The average Regulatory Strategy/Labeling professional spends 1 full week per month/per product conducting research and analysis activities related to labeling (this does not include administrative tasks and meetings).

One (1) Product X 480 hours per year X $150 per hour (average salary + bonus) = $72,000 per year/product

Pharmacovigilance (PV) role relates to the detection, assessment, understanding and prevention of adverse effects or other drug related problems. 

With DOC Label

  • Automate tracking of updates to areas of interest:
    • Competitor products
    • Therapeutic class
  • Monitor specific adverse events and boxed warnings as part of your signal monitoring program.
  • Monitor the evolution of REMS product labeling.
  • Monitor your compounds to learn when they are added to Drug/Drug Interaction sections of other labels:
    • Evaluate adding drug to your DDI section.
  • CCSI to local safety information comparison with DOC Label upload feature.

Without

  • Regularly check on DailyMed and FDA website for adverse events and other safety label updates, no automation.
  • No ability to monitor ADR’s or boxed warnings
  • Manually check REMS via FDA website
  • No way to automate drug interaction alerts
  • Manually compare CCSI info – 2/3 days per comparison

SIMPLE LABEL ANALYSIS: The average PV professional spends 1 full week per month/per product conducting research and analysis activities related to the safety sections of product labeling – including comparisons and monitoring of Warnings/Precautions, AE’s, Contraindications, Drug Interactions (this does not include administrative tasks and meetings).

One (1) Product X 480 hours per year X $150 per hour (average salary + bonus) = $72,000 per year/product

Medical Affairs plays a critical role in bridging R&D and marketed product support.

With DOC Label

  • Competitive intelligence/analysis.
  • Quickly compile information to respond to requests from physicians, payers, and internal stakeholders.
  • Significantly reduce time spent by senior staff and high-cost consultants.

Without

  • Manually complete competitive analysis with DailyMed or FDA website to support brand teams
  • No functionality – makes compiling data for request-response impossible.
  • Hire extensive consulting resources for label analysis. Costs upwards of $500,000 per year with no guarantee on accuracy or quality of comparisons.

OCCASIONAL LABEL ANALYSIS: The average Medical Affairs professional spends 2 weeks per quarter/per product conducting research and analysis activities related to commercial support/competitor labeling (this does not include administrative tasks and meetings).

One (1) Product X 320 hours per year X $250 per hour (average salary + bonus) = $80,000 per year/product

Identify new opportunities, including companies and products for acquisition, as well as identify new targets for development.

With DOC Label

  • Review the landscape of assets you are evaluating.
  • Create a TPP inventory of current on-market products.

Without

  • Unable to identify and examine all products with prior precedence with 100% certainty
  • Unable to create TPP of all products with 100% certainty
    • Unable to identify unique opportunities
    • Potential acquisition targets
    • Potential new formulations [505(b)(2) opportunities]

REGULAR LABEL ANALYSIS: The average Business Development professional spends >1 full week per month/per product conducting research and analysis activities related to labeling and clinical endpoints (this does not include administrative tasks and meetings) and prepare diligence documentation that includes analyses of many labels.

One (1) Product for Due Diligence X 480 hours per year X $150 per hour (average salary + bonus) = $72,000 per year/product

Have a deep understanding of their market, including the competitive landscape, which includes labeling, in order to differential their products.

With DOC Label

  • Monitor competitor labels:
    • Preparation of sales training materials
    • Internal executive presentations
  • Perform version comparisons of competitor labels to see what has changed
  • Save and follow searches: automated update notifications
  • Significantly reduce time spent by senior staff, high-cost consultants, and advertising agencies.

Without

  • No way to monitor competitor labels without daily checks on DailyMed and FDA website
  • No way to do version compare of competitor labels to see what has changed in their label from version to version.
  • No way to receive automated updates
  • Using advertising agency resources to perform these tasks at great expense

OCCASIONAL LABEL ANALYSIS: The average Clinical professional spends 1 full week per month/per product conducting research and analysis activities related to endpoint selection, TPP/TPC (this does not include administrative tasks and meetings).

One (1) Product X 480 hours per year X $150 per hour (average salary + bonus) = $72,000 per year/product

Identify new opportunities, including companies and products for acquisition, as well as identify new targets for development.

With DOC Label

  • Review the landscape of assets you are evaluating.
  • Create a TPP inventory of current on-market products.

Without

  • Unable to identify and examine all products with prior precedence with 100% certainty
  • Unable to create TPP of all products with 100% certainty
    • Unable to identify unique opportunities
    • Potential acquisition targets
    • Potential new formulations [505(b)(2) opportunities]

REGULAR LABEL ANALYSIS: The average Business Development professional spends >1 full week per month/per product conducting research and analysis activities related to labeling and clinical endpoints (this does not include administrative tasks and meetings) and prepare diligence documentation that includes analyses of many labels.

One (1) Product for Due Diligence X 480 hours per year X $150 per hour (average salary + bonus) = $72,000 per year/product

Create differentiated clinical trial designs so that your company can have differentiated labeling and promotion materials.

With DOC Label

  • Support drug development, including trial design.
    • Endpoints of interest - determine products that used this endpoint or a similar endpoint.
  • Create a TPP inventory of current on-market products.
  • Prior precedence

Without

  • Unable to search for all labels with an endpoint of interest
  • Unable to create TPP of all products without 100% certainty
  • Unable to identify and examine all products with prior precedence with 100% certainty

DETAILED LABEL ANALYSIS: The average Clinical professional spends 1 full week per month/per product conducting research and analysis activities related to endpoint selection, TPP/TPC (this does not include administrative tasks and meetings).

One (1) Product X 480 hours per year X $150 per hour (average salary + bonus) = $72,000 per year/product

Regulatory Intelligence for US, EU, and Canadian drug labels

  • Precision searching within specific label sections
  • Differentiate products with comparative reports
  • Natural language processing for label alignment
  • Access archived versions & redlined change logs
  • PLR & SPC mapping for regional comparisons
  • Monitor approvals & inform signal detection
  • Export reports to HTML, Excel, and Word formats
  • Access related agency communications

Search across the most recent USPIs, UK SPCs, Canadian PMs and EU SPCs 

Search across archived USPIs and UK SPCs

Search by indication, drug class, manufacturer, etc. and use filters to refine results

Ensure comprehensive searches by capturing all synonyms of search terms

Monitor labels, indications, and more with email alerts when labels are approved/updated

Compare label versions and receive immediate redlined copies when labels are updated

Use NLP to generate AE lists and compare different labels on a conceptual basis

Compare labels side-by-side in the browser

Export selected text or label sections to Word, Excel, and HTML; export Search Matrix report

Securely upload internal documents for comparative review

View Medication Guides (US) and Patient Information Leaflets (UK)

Access FDA Documents (e.g., Approval, Supplement, and Labeling Revision Letters)

Share searches with colleagues

See how DOC products can help supercharge your work!

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