An electronic regulatory affairs system can help standardize and streamline the essential functions of a regulatory affairs team, including coordinating and managing regulatory submissions with the R&D, quality, manufacturing, clinical research, and other teams. Regulatory affairs systems can greatly speed up the preparation and submission of post-marketing reports to various regulatory bodies.

Provide strategic guidance and regulatory solutions to deliver successful client outcomes that are scalable, flexible, and cost-effective. eCTD (electronic Common Technical Document) is a standard format of submitting Regulatory information (such as applications, supplements, and reports) to the concerned Health Authorities (HAs). It provides a harmonized solution to implement the Common Technical Document (CTD) electronically. We provide staffing/solutions/services in implementing eCTD Submission & publishing software’s for the following modules.

  • Planning & Tracking

  • Metadata Management

  • Registration Management

  • Submission & Publishing Management

  • Submission Validation

  • Submission Viewing & Reviewing

  • Pharmacovigilance Management

  • Administration

 

There are total five modules in eCTD

  • Region-specific information

  • Summary documents

  • Information related to quality

  • Non-clinical study reports

  • Clinical study reports (CSRs)

We also have expertise in implementing Document Life Cycle Management systems/solutions using Veeva Submissions, LiveLink & Documentum content management systems. Provide services in managing the FDA ESG (Electronic Submission Gateway) and European Medical Agency (EMA) Gateways.