A Strong Governance Backbone for an International Task Force
PLG’s solution combines global project management, central staff, and local experts for complete outsourcing of your regulatory and/or pharmacovigilance projects.
Project managers manage project planning, setup, and oversight; reporting; and client contact.
A central team oversees global regulatory strategy and provides regulatory affairs and operations support, CMC, medical writing, pharmacovigilance and safety, and publishing and labeling services.
Local teams conduct regulatory strategies and operational execution; they carry out deliverables; and they ensure quality.
PLG Guarantees Deliverables on Time and Right the First Time
Key success factors of the central-and-local-outsourcing operating-model solution are as follows.
- Setting objectives and expectations
- Establishing governance
- Defining processes and setting forth clear responsibilities
- Specifying deliverables
- Creating transparency and building trust
- Supporting change management when needed
- Setting key performance indicators
We measure success together
The main KPIs for the central-and-local-outsourcing operating-model solution are:
- Timely execution of deliverable
- Volume of deliverables
- Percentage of right the first time
- Number of deviations to process
- Client satisfaction
countries applying the central-and-local-outsourcing operating-model solution
Months to implement the model, depending on complexity
Headcounts working at PLG on the central-and-local-outsourcing operating-model solution
Keeping customers informed with monthly reports
Monthly budget for volume of work
- Per type of activity (variations, renewal, artwork, etc.)
- Per country
- Per region
- Per client product
Monthly forecasts of volume and budget based on client portfolio data
Risk analysis and remediation plan follow-up
- Free up time for other business opportunities and tasks
- Enhance business stability
- Improve oversight of tasks and requirements
- Simplify processes through harmonization
- Increase compliance
- Achieve better support from headquarters for affiliates
- Build inspection readiness
- Foster scalability
- Speed up establishment of new affiliates