Service content:

·  Process Sorting and Status Assessment:

o Comprehensively evaluate the company's existing eCTD publishing and application processes and identify efficiency bottlenecks and compliance risk points.

o Conduct in - depth analysis on aspects such as cross - departmental collaboration, document review, version control, and change management.

·  Process optimization and automation improvement :

o Based on lean management and automation tools, optimize the eCTD publishing and application process and improve overall operational efficiency.

o Integrate automation widgets to reduce manual operations and improve file consistency and accuracy.

·  Standard Operating Procedures (SOP) Development and Update :

o Develop or optimize standard operating procedures (SOPs) in accordance with global eCTD technical guidelines and internal enterprise procedures.

o Regularly update SOPs to ensure that they are consistent with the latest regulations and review requirements.

Our Advantages:

·  Full process coverage : SOP development and optimization encompass the full porcess of eCTD compilation, validation, submission, and maintenance.

·  Continuous improvement : Continuously optimize the eCTD publishing process and SOP through data analysis and feedback mechanisms.