This pharmaceutical major that offers a wide range of therapeutics, including innovative products for Oncology, Immuno-therapeutics, mental health, Infectious disorders, and Vaccines.
Required an EU-RMP authoring with expedited timelines and involved consolidation of multiple interim RMP updates.
This rare scenario of EU-RMP update appeared as a result of multiple updates based on parallel regulatory procedures for multiple target indications.
Due to regulatory variations requirements, the earlier RMP versions had multiple data-lock points and even multiple base versions.
The current regulatory sequence additionally demanded updates within short time span in multiple modules with newer data and change in the risk profile.
SIRO Solution:
SIRO pitched in to work with the client's Lead Writer and proactively proposed a sequential consolidation strategy to resolve the most critical consolidation challenge.
Besides providing technical solution, SIRO also provided swift authoring support to complement the EST – IST time zones resulting in doubling the speed of the work.
Key Takeaways:
Worked proactively hand-in-hand right from developing a strategy till finalization.
Overall process involved SIRO's close interaction with client's expert regulatory team and QPPV office.
