DoubleBridge delivers comprehensive eCTD publishing services, supporting sponsors from early development through post-approval maintenance.

Our services cover the full scope of electronic submission preparation, including document formatting, dossier assembly, lifecycle operations, metadata management, and validation checks. We ensure submissions are aligned with ICH guidelines and regional regulatory specifications.

‍Supported submission types include:

DoubleBridge provides holding-equivalent regulatory services to support ongoing compliance for active applications, including IND, NDA, BLA, and ANDA. Our services include:

Annual fee coordination and tracking

Registration and listing maintenance

Sponsor and contact information updates

By managing these ongoing obligations, we help ensure that applications remain current, compliant, and prepared for continued FDA interaction, inspections, and lifecycle events.

DoubleBridge provides FDA ESG Next-Generation submission services to support secure and compliant electronic filing.

As an organization maintaining an active FDA ESG NextGen account, we manage the technical and procedural aspects of submission transmission on behalf of our clients.

Our ESG services are designed to minimize submission risk and ensure smooth interaction with FDA electronic gateways for both emerging and marketed products, which includes:

As your designated FDA U.S. Agent, DoubleBridge serves as the official point of contact between your organization and the U.S. Food and Drug Administration.We facilitate regulatory communications, receive and manage FDA correspondence, and ensure timely notification handling throughout the submission, review, and post-approval phases.

This service is particularly critical for non-U.S. sponsors seeking to maintain continuous compliance with FDA requirements.

Our US Agent services help ensure regulatory continuity and clear communication across the entire submission lifecycle.