Why Choose Our eCDT Services
FDA & EMA Compliance
Seamless eCTD Submissions
.png)
Expert Regulatory Support
What is eCTD
and Why is It Important?
The eCTD submission process is essential but complex, required for INDs, NDAs, DMFs, and more. It can be resource-intensive, posing operational and cost challenges. ClinReg Partners offers comprehensive eCTD services to simplify regulatory publishing and ensure compliance, helping you avoid delays and streamline approvals.
Our eCTD Services
At Clinreg Partner, we provide expert eCTD publishing services, handling INDs, NDAs, DMFs, and BLAs with precision. Our team ensures seamless, compliant submissions tailored to your needs.
eCTD Preparation
Properly structure, format, and hyperlink documents to ensure regulatory compliance and seamless submission.
Submission Management
Handling IND, NDA, ANDA, BLA, and eDMF submissions, including amendments and lifecycle maintenance.
Project Management
Coordinate regulatory submissions from start to finish, ensuring efficiency, accuracy, and full compliance.
FDA Gateway Submission
Transmit regulatory submissions securely via FDA-compliant gateway with 21 CFR Part 11 encryption.
Helping You Navigate Regulations
At Clinreg Partner, We simplify eCTD submissions with expert guidance, ensuring compliance, accuracy, and a seamless process.
Preparing eCTD
and Document Formatting
A well-structured eCTD submission ensures compliance, clarity, and fewer errors for faster regulatory approval.
📄 Proper document formatting & compliance
🔗 Hyperlinking & cross-referencing
📁 XML backbone creation for eCTD submission
✔️ Validation & Quality Checks
Submission Management
and Filing of Applications
We manage regulatory submissions with precision, ensuring compliance for IND, NDA, ANDA, BLA, and eDMF.
📤 IND, NDA, ANDA, BLA, & eDMF Submission
♻️ Lifecycle Updates and Maintaining document
📈 Tracking and Maintaining Submissions
💾 Electronic Publishing & Formatting
Project Management
and Regulatory Support
Our project managers coordinate regulatory submissions, ensuring timely execution, compliance, and efficiency.
📋 Regulatory Strategy Planning
⚠️ Risk Management & resolving issues
⏳ Timeline Management and Submission schedules
📊 Progress Monitoring Overseeing submission status
FDA Gateway Submission
and Secure Transmission
Our project managers coordinate regulatory submissions, ensuring timely execution, compliance, and efficiency.
📡 21 CFR Part 11 compliant encrypted submissions
✅ Ensuring FDA, EMA, and ICH standards
📜 Submission Tracking & Archiving
🛠️ Error Identification & Resolution
Frequently Asked Question
Quick Answers to Your eCTD Questions
