Business Imperatives
A Dubai-based healthcare company sought Freyr’s Regulatory expertise for the initial registration of Paclitaxel PhaRes with SFDA. The scope included gap analysis, document review, eCTD dossier preparation, validation, and submission coordination.
Objectives
To achieve the successful SFDA registration of Paclitaxel PhaRes by ensuring compliance with Regulatory requirements, addressing documentation gaps, and streamlining the submission process for a timely and seamless approval.
Problem Statement
The client faced challenges due to unfamiliarity with SFDA’s submission process, Regulatory complexities, and strict timelines. As a new applicant, they lacked clarity on requirements, posing a risk of delays and non-compliance.
