Supporting the Full Approval of a Life-Saving Bacterial Vaccine
- Client: A Global Pharmaceutical Company
- Year: 2020-2022
- Impact: Ensured regulatory compliance, expedited approval, protected vulnerable populations.
A global pharmaceutical company sought full regulatory approval for a Life-Saving Bacterial Vaccine, requiring a seamless and precise SDTM submission. Given the complexity of regulatory expectations and evolving data requirements, the process demanded careful coordination and rapid execution.
As part of the SDTM team, we managed:
- Multiple rounds of regulatory data requests, ensuring all adjustments were completed accurately and on time.
- Structural refinements to SDTM datasets, adapting to evolving submission standards.
- High-pressure deadlines, where every update had to be executed flawlessly to maintain submission timelines.
Through meticulous data management and a structured approach to regulatory compliance, the submission was successfully completed, leading to the full approval of the vaccine in 2024. This achievement not only solidified the vaccine’s place in public health strategy but also demonstrated the critical role of precise and agile data handling in the regulatory process.
