The FDA Electronic Submissions Gateway (ESG) serves as an agency-wide platform for receiving regulatory submissions electronically. It's designed to be highly scalable, easily accessible, and secure, providing a high-performance exchange point for the FDA and its partners to manage various documents and submissions using standard industry protocols. The FDA ESG allows for the secure submission of both premarket and postmarket regulatory information for evaluation. It functions as a central entry point for receiving and processing all electronic submissions within a highly secure environment.

The Electronic Common Technical Document (eCTD) is an international standard format for submitting applications, amendments, supplements, and reports to regulatory agencies in the pharmaceutical industry. Developed by the International Council for Harmonisation (ICH), eCTD ensures a consistent and efficient way to transfer regulatory information between pharmaceutical companies and regulatory authorities.

eCTD submissions are structured into five modules, which include region-specific information, summary documents, quality-related information, nonclinical study reports, and clinical study reports. This format is used by regulatory agencies such as the FDA's Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER).

Regulatory Affairs (RA) and Regulatory Operations (RO) play unique yet complementary roles in the life sciences sector. Here's a breakdown of each:

Regulatory Affairs (RA)

• Core Focus: Developing strategies and ensuring compliance with regulatory requirements.

• Key Duties: Crafting regulatory strategies, preparing and submitting dossiers, ensuring adherence to regulations, managing labeling and promotional activities, and overseeing post-market surveillance.

• Primary Role: Acting as intermediaries between the organization and regulatory bodies, guiding product development, approval processes, and post-market compliance activities.

Regulatory Operations (RO)

• Core Focus: Managing documentation and the logistics of regulatory submissions.

• Key Duties: Handling documentation for regulatory submissions, preparing and formatting documents for submissions like eCTD, coordinating submission schedules, and maintaining quality control.

• Primary Role: Overseeing the logistical aspects of document preparation, submission, and tracking to ensure timely and accurate regulatory submissions.

In essence, RA is focused on strategic and compliance aspects, while RO handles the practical aspects of managing and submitting regulatory documents.

The lifecycle of a regulatory submission involves several stages:

1. Planning and Preparation: Identifying regulatory requirements, gathering necessary documents, and creating a submission plan.

2. Document Creation: Compiling, drafting, and reviewing documents to ensure they meet regulatory standards.

3. Submission Compilation: Organizing documents in the required format, such as eCTD, and ensuring all necessary components are included.

4. Quality Review: Conducting thorough checks for accuracy, completeness, and compliance with regulatory guidelines.

5. Submission: Sending the compiled submission to the regulatory authority through the appropriate channels.

6. Post-Submission: Addressing any feedback or requests for additional information from regulatory authorities and monitoring the status of the submission.

To prepare and submit eCTD (Electronic Common Technical Document) submissions, you'll need specialized software that can handle the complexities of regulatory document management and submission.

Pointerro uses Lorenz docuBridge - An advanced electronic submission management and regulatory content management system that supports multiple formats offers features like team collaboration, lifecycle management, and flexible content reuse. FDA employs a similar but larger production version of Lorenz docuBridge.