Customer/project Understanding

Context & challenge 

Customers need to update old products dossier in accordance with Eurasian requirements. Both MW and RA competencies required

Current scope

  • Conduct a Gap analysis on 11 products’ dossiers.
  • Preparation of module 2 (2.4-2.5-.2.6.-2.7), 4 and 5, SmPC and PIL Preparation for the Russian Market.
  • Flexibility to manage the various steps involved in dossier submission, which are (1) preclinical or clinical study analysis, (2) tabulated-summaries preparation, (3) overview writing, (4) quality control, (5) review cycles (at least two), and (6) reformatting.

Team

3 MW – 1 coordinator

Customer Benefits

On-Time-Delivery (OTD) and Right-First-Time (RFT) KPIs.

Both Medical writing and Regulatory experts acting in the same team: regulatory tasks (SmPC/PIL writing and readability tests) planned directly with the MWs.

Continuous improvement, with the objective to anticipate issues and implement or verify efficiency of action plans.

Solution provided by PLG

Our end-to-end global outsourcing model‎

  1. Process: Extended scope, with management
    of complete processes.
  2. Back-up: In place for each activity with various solutions including cross-teams partial back-up solutions to ensure continuity of activity or additional support.
  3. Coordination: Team coordinators acting as technical referees, managing priorities, distributing the tasks/projects within the team, giving priorities and managing the close reporting to the client and a full QC of the documents.

PLG success factors

PLG adaptability to customer evolutions with adaptation of the operating model, Workload evaluation, distribution, planning and forecast.

  • Direct contact with both Medical and Regulatory Customer’s Department, facilitating the review process and the workflow
  • Local language (Italian) speaker
  • Flexible handling of workload peaks
  • PLG Growing autonomy resulting in time saving for the customer.
  • Back-up management: activities maintained whatever missing resources.

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Global Life-Cycle Management, E2E global outsourcing model