We offer comprehensive support for eCTD submissions. Our approach is based on ongoing collaboration and knowledge transfer, ensuring that you and your team are fully prepared and compliant with the latest eCTD regulatory requirements. Our team members are strategically located to cover all time zones and ensure that submissions are made in a timely and efficient manner. We have well-defined processes in place to continually improve consistency, efficiency, quality control, and risk mitigation. Our services include eCTD submission strategy, project management, compilation, validations, submissions via gateway, and lifecycle submission management to ensure compliance throughout the product's lifecycle.
Our services for Word formatting and publishing documents ensure that your submission documents meet the eCTD PDF specification requirements. We take care of the technical details so that you can focus on the content of your document. The CTD Word template suite is designed to simplify the process of creating compliant submission documents, allowing clients to focus on the content rather than formatting. With a common structure and an easy-to-use toolbar, the templates enable users to quickly apply commonly used styles. By implementing the template suite, authors can streamline the process, ensure consistent formatting, and save time and effort.
Our team provides operational support for regulatory aspects of clinical trials including support with transparency and disclosure (redaction services), support in the EU Clinical Trial Information System (CTIS), ensuring that EU CTAs are completed in a timely and efficient manner. Our expertise extends to managing the complexities of the Clinical Trials Regulation (CTR) and Policy 0070 disclosure requirements, enabling clients to navigate this evolving regulatory landscape with confidence.
