Transforming eCTD pre-publishing

Transforming eCTD pre-publishing

The large volume and intensity of administrative work involved in eCTD publishing requires a ground-breaking approach within regulatory affairs and operations. The evolving landscape requires a transition towards transforming workload management with real-time data monitoring and reporting.  

Our automated Publishing Assistant acts as a document checker and structure builder to ensure complete and efficient compliance with the ICH eCTD v4.0 standard. With our commitment to reshaping workload management, our Pre-Publishing Automator guides you toward enhanced efficiency, precision, and adaptability in the dynamic landscape of regulatory affairs. 

Taking a significant step toward a successful pre-publishing automation

Taking a significant step toward a successful pre-publishing automation

Preparing and publishing regulatory documents requires high quality and adherence to stringent standards. At PLG, we redefine regulatory document preparation with our tech-enabled service, ensuring high quality, accuracy, and compliance. Our meticulously validated automated process aligns seamlessly with all regulatory requirements, enhancing efficiency and streamlining operations within the eCTD framework. By automating routine tasks, our service simplifies workflows, eliminates email exchanges, and empowers publishing experts to focus on value-added activities, boosting overall productivity.  


With the possibility of a progressive extension with validated automation, our service continues to adapt and provide process optimization in the regulatory landscape with a versatile rule-based approach applicable across various automation contexts. Take a step further with our Pre-Publishing Automator, promising streamlined operations, heightened accuracy, and unparalleled excellence. 

With Pre-Publishing Automator, we release a huge amount of operational time for more added value activities while guaranteeing a high quality and efficiency, regardless of the amount of processed content.

Fadime Kale

Publishing & Submission Management Global Lead, ProductLife Group

Fadime Kale – Publishing Automation

You can read more information about Publishing here:

Publishing Automation