- Increase your on-time submission delivery KPI
- Increase the quality of the submission deliverables
- Replace firefighting by a stable working environment
- Boost collaboration between regulatory teams
- Engage contingent workforce when you really need it
- Give end-to-end visibility, which leads to productivity
- And most of all, bring the benefits of new treatments sooner to patients
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?
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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.
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
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
4. Standardize work and win, twice
Standardizing work items in regulatory affairs might seem difficult at first sight, but it is a winner’s effortEven 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
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?
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
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.
"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