Global Life-Cycle Management, E2E global outsourcing model

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.

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.