Labeling Content & E2E Project Management

Whether you are planning a new product development or expanding your current product for new indications or patient population, knowing “what’s out there” is one of the key initial steps. Label Intel helps you do just that. With over 300K approved labels (both drugs and devices) pre-loaded and updated daily, you can subscribe to alerts when new labels matching your criteria added in DB.

Compare Labels by drug exposure and clinical response variability, mechanisms of drug action, polymorphic drug target, genotype-based dosing, disposition pathways, risk for adverse events, precautions/alerts, drug–drug interactions, contraindications, and nutritional management across the medicines and medicinal products.

End-to-End labeling management is every labeling organization’s deep desire/ambition. With content in some EDMS system and regulatory changes in other systems, this has been a nice-to-have action as opposed to must-to-have activity.

With our solution, complete end-to-end labeling management tracking is possible from change requests, workflows, metrics, assessments, content linkage, templates, approvals and, tracking enabling labeling teams to manage Product Information and labeling documentation. Workflow and smart sheets automate client operations (regulatory labeling) to handle repetitive, labor-intensive tasks, including data extraction, review, and management to help drive significant productivity and compliance across labeling processes. E2E labeling solution improves processes and increase business value for your regulatory or labeling teams or business leads.

1. Process Management
   • Support end-to-end labeling processes, including labeling change management and regulatory compliance tracking
   • End-to-end traceability and consistent oversight with strong process control
   • Cross-functional deep collaboration on global and local/country level (through task assignments, auto alerts, metrics tracking)
   • Automate Health Authority or Regulatory Body data/content exchange
   • Interact/Communicate with other stake holders like Artwork and Supply chain teams with minimal touch points (through tool with simple workflows)
2. Content Management
   • Manage labeling data and documents through a single repository at local and international level
   • Manage, reuse and control product information throughout its lifecycle
   • Manage country dependencies per product
   • Reuse or repurpose approved content from a central resource
3.  Integration / BPM
   • Leverage your current EDMS or RIM where we can complement or fill gaps in your current systems/processes
   • Integrate to your SAP/ERP for labeling artifacts exchange
   • Regulatory intelligence (125 countries) already integrated

Big Pharma Challenges

• Sometimes embedded in Regulatory and often less important in terms of resources or budgets (especially when these are de-centralized)
• Usually, most of the labeling is manual, copy/paste & repetitive, manual reconciliations of data points, a lot of QC checklists, and so on
• Heavily document focused and digitization is always “next year” project
• Having separate labeling focused software tough to justify cost and sustenance

Mid/Small Pharma Challenges

• With fewer products in the market, a labeling system not on priority to the Finance team
• Maintained in documents (on desktops, shared drives, or general EDMS) and with less traceability
• Less time left for actual “science” work
• Knowledge in fewer hands (out of the door when they leave)

Core Labeling: The Solution enables you to “digitally” create and maintain the lifecycle of all core labels like CCDS/CCPI and some key labels like SmPC/USPI linking to CCDS. With effective impact analysis built-in, decide effective changes and once done, trickle-down those to other labels thereby reducing manual copy/paste and QC aspects.

Local Country Labeling: With live Reg intel built-in, local country labeling (both new and maintenance) saves you over 70% of the time. With few clicks, you can do change control, analyze data, assessment, compare CCDS changes, and update/finalize local label content. Includes multiple comparisons (more than one local label and CCDS), hybrid comparisons (EU SmPC, CCDS, USPI, and local label), regulatory submission-type comparison, Localization, and QC.

Label Compliance: As all labeling content and actions are linked well in the tool, Compliance management is at ease. All local label deviations and local deviation safety compliance can be viewed by simple reports by change, by version, by country, and by the user. HQ team also will have options to set rules/controls for alerts on deviations.

Change Management: Regulatory change management is included where variations can be proposed, created, and tracked until implemented in the core labels. Changes proposed for core labeling processes are extended sequentially to the processes at each level (LPD, Artwork, Printing, and Supply Chain). Our solution can recognize the countries impacted by the proposed labeling changes and notify the concerned stakeholders on the change, well before the CCDS distribution.

Software Cost Justification: For companies who cannot justify labeling focused separate software, with REGai platform, other processes or functions like regulatory affairs or Reg Ops or QC can be leveraged by other teams in the same platform thereby building a proper “Business” case with Finance and IT.

In most companies Labeling QC is a Manual process. Whether you do in house, outsource or offshore, Manual label QC is NOT acceptable when technology and options are available. Even if you outsource some of these, you are still spending time as part of “Oversight” that costs you time.

Several research articles and surveys point that QC takes 10% to 30% of overall time in Label content life cycle. Imagine if the labeling associate or a senior resource is doing this task, you can do the math based on how many documents are being QCed per month. You can stop or minimize this $$ drain and free up time for your resources to do more value add tasks. Not just $$, but Cycle time can be improved drastically for faster turn-around.

We automate QC. With 400+ QC checks built-in, you pick what QC to apply to which document (USPI or SmPC or RPI or other labeling documents). You are in control as all this is done using a simpler user interface that’s cloud-based.