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.
