REGULATORY AFFAIRS

HELPING CLIENTS TO SOLVE COMPLEX PROBLEMS, REDUCE COST AND FREE UP RESOURCES TO ADD MORE VALUE

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WHAT WE DO

WE HELP CLIENTS TO SOLVE COMPLEX PROBLEMS, REDUCE COST AND FREE UP RESOURCES TO ADD MORE VALUE.

We work with clients to create a new vision for the future of their Regulatory Affairs function, complete with the capabilities and capacity they will need to keep pace with the “shifting sands” of the regulatory landscape.

We help teams to design visually managed, lean processes, and roles to support those processes. We assist you to develop excellent external partnerships which will facilitate an ultra-efficient resourcing model and deliver measurable benefits back to the business.

We support you to realise your new vision through an internal start-up approach, where we can grow what works best into a new, transformed, higher-value adding organisation.

THE BENEFITS

KNOWLEDGE

Significant improvements in the retention and application of regulatory knowledge leading to better informed strategic and commercial decisions and plans.

COST

External sourcing of operational elements, facilitated by strong partnerships and streamlined processes can bring significant cost savings, and release internal resources for higher value activities.

RISKS

Enhanced visibility and transparency will mitigate compliance, strategic and commercial risks and facilitate expedited resolution of business-critical issues.

SPEED

Significant improvements in ability to fulfil commitments in parallel rather than in sequence and deliver Global Regulatory Submission Speed.

PROCESS INNOVATION IN A GLOBAL REGULATORY AFFAIRS ORGANISATION

How a major pharmaceutical company re-imagined itself and the service and value it delivers to its customers.

READ THE CASE STORY

THE POWER

OF VISUAL

Avellana are experts in the implementation of virtual visual management for dispersed and remote teams and have successfully implemented visual management in multinational Global Regulatory Affairs organisations.

Visual Management creates effective and agile teams that ‘know what is going on’ at all times. We advocate using state-of-the-art cloud based visual, Lean tools to make it easier for teams to align where they spend their time with where they add most value.

The ability to visualise workload, priorities, issues and risks will transform your organisation and release the value in your data. More importantly it will allow your people and teams to collaborate effectively, see the most important thing to do and see how to help each other.

No more clumbsy hand-offs and malfunctioning interfaces. Virtual Visual Management makes collaboration easier and more effective and will make your teams more productive and break down the silos.

SAFE AND EFFECTIVE

USE OF EXTERNAL

REGULATORY SUPPORT

We believe external partnerships are an essential part of an efficient regulatory operations strategy. And forging successful relationships with partners requires careful planning to ensure smooth transitions without disruption or risk to the business.

We help companies to …

  • Define their needs from an outsourcing perspective and their requirements from an external vendor
  • Identify critical control points and targets for externalization
  • Create harmonized and standardized processes that support external partner involvement
  • Create appropriate hand-offs and visualisation of externalised work
  • Create a governance structure and key performance indicators to manage the relationship

 

LEAN INNOVATION IN REGULATORY AFFAIRS

Watch our 2 minute video!

THE NEWEST FROM OUR KNOWLEDGE CENTRE

Regulatory Outsourcing- No alarms and no surprises please!

Outsourcing of regulatory support has been on the rise over the last decade and it is now a common practice. The Annual RIM Whitepaper 2016 by GENS & Associates stated that “ Since 2014 outsourcing has been considered a common practice with many qualified...
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When you can see it, you can fix it.

Teams that manage their work visually have a serious advantage.   They know what is happening.  They know who is doing what, who needs help, and who has room to help.   And when something goes wrong, it doesn't hide, it calls out for attention and the team can fix it...
Read More

HAVE QUESTIONS? WE'D LIKE TO HELP

 

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