• eCTD development (creating folder structure, defining the contents within the folders, designing the XML backbone, developing Study Tagging file, hyper linking, SAS integration, etc.)
• Designing and developing in-house electronic publishing capability
• Integrating off-the-shelf tools with existing systems and workflow management
• Developing processes, preparing documentation and creating data architecture for IND, NDA, BLA, ANDA, OTC, NADA, ANADA, Adverse Event Reporting, etc.

Xyntek’s with proven experience in all the phases of Drug Development Life Cycle, will work with your prime resources: people, processes and technology; add through understanding of latest FDA/ICH eCTD guidelines, to realize e-Submission of your innovation. All of Xyntek's business solutions are developed in accordance with our stringent Project Management & Software Development Life Cycle (SDLC). We ensure that our solutions meet your business and process requirements from initial Process Definition to Detailed Design & Development, Implementation, Compliance, Training, and Long-term Support.