The electronic Common Technical Document (eCTD) is a critical component of regulatory submissions in the US and EU. At confinis, we specialize in writing and compiling the necessary sections of eCTD, ensuring that all regulatory requirements are met. Our team is skilled in creating clear, detailed, and well-organized documentation that facilitates smooth regulatory review and approval.

We work closely with clients to gather the necessary data and information, ensuring that each section of the eCTD is accurate and complete. Our expertise in regulatory writing and submission processes helps clients navigate the complexities of eCTD submissions, reducing the risk of delays and enhancing the likelihood of approval.