Electronic Common Technical Document (eCTD)
Bringing together complex data from different fields and departments is challenging and a complex task. Learn how IASON consulting can assist you in the preparation of your eCTD.
eCTD structure
We meticulously adhere to the eCTD structure as provided by the ICH and rigorously ensure full compliance with all regulatory requirements.
All modules
Our comprehensive capability to prepare all eCTD modules ensures best document quality, coming from a single expert hand.
XML files
We also possess the expertise to create the eCTD XML backbone file structure to provide you with a ready-to-submit submission folder.
Our strengths
Experts in many fields
At IASON consulting, our dedicated team has a rich spectrum of expertise spanning the essential fields required for compiling comprehensive eCTDs. With specialists in regulatory affairs, clinical research, toxicology, pharmaceutical manufacturing, software development, and more, we possess the unique capability to expertly assemble all eCTD modules. This holistic approach ensures that your eCTD submissions are meticulously crafted, compliant, and of the highest quality, streamlining the regulatory approval process for your pharmaceutical products.
Our experience
Since 2004, we assist companies in both the pharma and medical device sector to successfully bring their products to the market. Our depth of knowledge and extensive industry experience ensures that your eCTD projects are handled with the utmost professionalism, efficiency, and compliance, empowering you to navigate the regulatory landscape confidently.
New eCTDs, updates & amendments
With over two decades of experience in the field, IASON consulting offers a comprehensive suite of services tailored to your eCTD needs. Whether you're looking to create new eCTDs from the ground up, update existing submissions to meet evolving regulatory standards, or prepare precision-crafted amendments, our seasoned team is here to assist you every step of the way.
Frequently asked questions
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