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End-to-end visibility as the key to optimize resource planning in regulatory affairs

How a global pharma player keep their regulatory submission process in control and deliver on time?

binocs screenshot: demand is everywhere
See the occupation of a variety of regulatory affairs roles such as pre-clinical, clinical, CMC, labeling, production, engineering and project management

Pharma - Global Regulatory Affairs - 400p - 35 teams across multiple regions - 1000s of submissions/year

When drawing up the planning of highly skilled resources, such as in regulatory affairs, team leaders and regulatory leads need to be able to anticipate and see capacity roadblocks long ahead. Resource availability needs to be clear at all times, as having the right persons at the right time is crucial in regulatory submissions.

In life science industries, regulatory submissions are the most critical milestones in new product developments and the product’s lifecycle. A correctly planned submission process really makes the difference because you:

  1. Increase your on-time submission delivery KPI
  2. Increase the quality of the submission deliverables
  3. Replace firefighting by a stable working environment
  4. Boost collaboration between regulatory teams
  5. Engage contingent workforce when you really need it
  6. Give end-to-end visibility, which leads to productivity
  7. And most of all, bring the benefits of new treatments sooner to patients

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30' business value track
90' sightseeing track
  1. 1. Just visualize it

    This is where resource planning visibility is a true game changer

    • Binocs allows you to identify capacity risks far more easy.
    • With the Binocs cloud based resource planning tool, you can plan the optimal flow of your regulatory submission processes
    • You'll easily create dashboards and views to look at capacity questions from different angles.
    More detail on demand in your RA departement
    binocs screenshot: create end-to-end visibility on your regulatory submission planning and capacity requirements
  2. See the occupation of a variety of regulatory affairs roles such as pre-clinical, clinical, CMC, labeling, production, engineering and project management

    2. Get capacity answers promptly

    Even in a complex environment like regulatory affairs

    • Organize and plan your RA staff around a broad variety of regulatory authority submission demand
    • Engage a wide span of competences such as pre-clinical, clinical, CMC, labeling, production, engineering and project management
    • Keep track of all workload in one single place
    Dive into managing available capacity for regulatory affairs
  3. 3. Easily collaborate, in compliance

    Regulatory project leaders need to ensure that the sequence of submission activities is executed correctly

    • Binocs helps teams to collaborate in a structured way, as it visualizes the interaction within and across submissions
    • The online planning application uncovers the root cause of future resource capacity problems and allows managers to act way before the team is put in firefighting mode
    Regulatory activities are sequenced automatically by Binocs.
  4. Standardize your regulatory activities and win on submission performance. Boost your publishing KPIs!

    4. Standardize work and win, twice

    Standardizing work items in regulatory affairs might seem difficult at first sight, but it is a winner’s effort

    Even when workloads may vary every time again, such as a CMC writer having to document a process change, you can still categorize it into typical work items. By defining standard work items, your organization wins twice:
    • Teams will execute activities more efficiently
    • Delivering on time never before was this easy
    Learn more on reporting in binocs
  5. 5. Surf on your submission management system

    We translate your submission events into work sequences

    • Import and sync the latest submission and publishing status from systems like Liquent
    • Through a work configurator, Binocs is able to translate your submission events in to sequences of tasks that are planned across your RA organization
    • You input your submissions like before. No extra data input needed in Binocs. Just use the Binocs planning output. Cool, isn't it?
    Events in your submission dossier management system are translated into workload sequences in a split second.
  6. Don't wait until the issues hit you. With what-if scenarios you'll see issues early so you still can implement solutions.

    6. Anticipate with what-if

    Build multiple “what-if” scenarios to anticipate on challenges

    • Play around and run scenarios without affecting the "official baseline". It's easy and fast. Everybody can run scenarios.
    • Discover staffing needs. See where exchanging resources between teams helps. Identify from which operational excellence initiatives you'll benefit the most.
    • Compare solutions to decide upon the best option
    More info on analyzing capacity and handling scenarios
  7. Project approach: start small, win quickly

    Introducing a new way of working has never been a burden in Binocs implementation projects. The Binocs team helps you to focus on the most important submission activities first, paving the way to success. Even when you start small, you can immediately make important efficiency progress visible in your organization.

    “What if” you could stop firefighting?

    Some of the world's biggest brands trust Binocs to plan their resources. View all bluecrux clients.

    • GSK
    • Pfizer
    • UCB

    "Binocs offers tangible benefits for Regulatory Affairs Operations"

    Create end-to-end planning visibility
    Easily identify resource capacity risks - no more firefighting
    Easy collaboration between teams
    Integrate with submission and dossier management systems
    Standardize work and accumulate on-time submissions
    Create transparent dashboards and report
    Easy to use via a user-friendly, always available web-based interface

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