Service content:

· End to end service :

o Full-process one-stop service: full-process services covering eCTD preparation, validation, submission and maintenance, helping enterprises save time and effort.

o Quick response: Complete the preparation, verification and submission of eCTD files in the shortest time to ensure that the application progress is not delayed.

o Automation Tool Integration: Introduce advanced eCTD publishing software and verification tools to minimize manual errors and improve data consistency and file integrity.

o High-quality dossier production and verification: compile and format the eCTD module according to the requirements of major regulatory agencies (such as NMPA, FDA, EMA, etc.). Such as: localization and compliance inspection of M1 administrative documents; structured organization and labeling of M2-M5 technical documents, etc. Use industry-leading verification tools to conduct a comprehensive inspection of eCTD documents to ensure compliance with the technical standards and compliance requirements of major regulatory agencies.

o Update maintenance: Respond quickly and update eCTD documentation according to the latest regulatory requirements to maintain the continuous compliance of application dossier. For example, for Supplemental Applications and Annual Reports, provide fast and efficient eCTD update and maintenance services.

o Efficiently support simultaneous registration in multiple countries and regions around the world: quickly, accurately and efficiently support registration in multiple countries and regions through the reuse of technical documents (M2-5).

·  Partical outsourcing service:

o Tailored to the capabilities of the enterprise's team, we offer modular eCTD publishing services. For instance, we provide outsourcing services specifically for the validation, submission, and update processes, among others.

o Flexible Combinations: Our services can be customized to meet specific requirements. This includes tasks such as localizing administrative documents, compiling technical modules, bookmark and hyperlinking, and more.

Our Advantages:

·  Efficient delivery : Have mature eCTD publishing process and automation tools to ensure the preparation and submission of eCTD files quickly, efficiently and accurately.

·  Flexible cooperation : Flexible adjustment of service content and delivery cycle according to customer project progress and needs.