.svg){kind=icon}
Deliver Regulatory Submissions with
Confidence, Speed, and Control.
ROSETTA combines purpose-built software products and expert services to ensure
compliant, efficient submission delivery — ready for eCTD v4.0.
We combine deep regulatory expertisep with ROSETTA eCTD software products
to deliver compliant, timely, and cost-efficient submissions
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:
DoubleBridge provides FDA ESG Next-Generation submission services to support secure and compliant electronic filing. This 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:
.avif)
.avif)
.avif)
.avif)
Our Proven Process to Drive Your Rugulatory Success
.svg)
.svg)
.svg)
