At DoubleBridge, we specialize in partnering with top-tier Regulatory Affairs experts to handle the complexities of global product approvals.
Our team prepares the critical documentation required for agencies such as FDA, EMA, and Health Canada, ensuring your submissions meet all regulatory standards.
At DoubleBridge Technologies, we offer a full suite of eSubmission services tailored to meet your regulatory needs:
• Seamless project management for regulatory submissions across all stages
• Initial preparation, submission, and ongoing maintenance of INDs, NDAs, ANDAs, BLAs, and eDMFs
• Specialized country-specific submission composition, validation, and publishing for FDA and EMA
• Comprehensive formatting, editing, and hyperlink verification to ensure submission readiness
• Expert preparation and organization of submission documents and cross references
• Efficient preparation, publishing, and management of amendments and supplements
• End-to-end document authoring and translation services to support global compliance
• Secure and reliable submissions using our FDA-compliant company gateway
• Access to our intuitive, cloud-based software portal for streamlined and timely submissions
• Safe and compliant eCTD file storage and archival on our 21 CFR Part 11 secure servers
End-to-End Submission Management
From dossier preparation to submission and lifecycle management, we've got you covered!
Navigating the eCTD format can be challenging, but we make it seamless. By aligning every submission with ICH, FDA, and EMA requirements, we enable your internal team to focus on drug development and strategic initiatives, helping you accelerate your product's journey to market.
eCTD v4.0 Consulting and Assistance
Stay ahead in regulatory excellence — embrace eCTD v4.0 with our expert support and innovative solutions!
Ready to take the next step toward the future of regulatory submissions with eCTD v4.0? We're here to make your transition seamless and successful. Let our expert team guide you with professional services and cutting-edge compliance tools designed to keep you ahead of the curve.
Why Choose DoubleBridge Submission Services?
Expertise: Decades of experience in regulatory submissions.
Comprehensive Solutions: Integrated tools and services for complete compliance.
Customer-Centric: Tailored solutions to meet your unique needs.
Interested in outsourcing your submissions to our experts?
Contact us for a personalized consultation or demo today.