easyTD
The Electronic Common Technical Document (eCTD) is the standard format for submitting applications, amendments, supplements, and reports to FDA’s Center for Biologics Evaluation and Research (CBER) and Center for Drug Evaluation and Research (CDER). An eCTD submission has five modules: region-specific information, summary documents, quality-related information, nonclinical study reports, and clinical study reports.
eCTD is an intelligent publishing software which is seamless for eCTD submissions. To ensure smooth seamless submissions, life sciences organizations must consider the wide variety of documentation they need to manage and the entire documentation lifecycle covers a complete clinical and pre-clinical research data accumulated over the years. Also, region-specific submission requirements vary depending on the respective Health Authority (HA) regulations and, thus, the submission templates and formats.
The Common Technical Document (CTD) was developed by the International Conference on Harmonization (ICH). The format is becoming popular and most preferred by regulators in the world’s major marketplaces. eCTD has been mandated for marketing and post-marketing applications in Europe, Japan, and Canada. eCTD is an XML-based version that is submitted via electronic media or directly through secure regulator gateways. eCTD format enables pharmaceutical companies to submit applications to various regulatory authorities such as the FDA without altering the data.
Some of the significant application types are:
Fransha Pharma LLP offers a ready to use eCTD software, pre-validated, and highly secure cloud-based regulatory compliance suite. Our software has been built to fulfil organizational needs holistically and end to end. Our Innovation and vision is to keep it as simple as possible while delivering compliance and fulfilling FDA 21CFR11, EU Annex 11, ICH, and GxP requirements.
easyTD is a ready-to-use, flexible, and cost-effective (Lowest cost in the industry) web based solution for submitting the content electronically with regulatory authorities. Its superlative lifecycle and metadata management process make the long submission process more comfortable and practical. Our document management system docuDrive can be interfaced with this system to make the compilation process easier. The solution also supports the submission process for medical devices.