Client Overview:
Client Overview:A mid-sized biopharmaceutical company developing an innovative oncology drug approached us to assist with their Investigational New Drug (IND) submission in the electronic Common Technical Document (eCTD) format. This was their first eCTD submission, and they faced challenges in structuring their application, ensuring compliance with FDA requirements, and managing tight timelines.
Challenges Faced by the Client:
- Lack of eCTD Expertise – The client had never submitted an IND in eCTD format before.
- Complex Document Compilation – The submission required multiple modules, including preclinical and CMC (Chemistry, Manufacturing, and Controls) data.
- Validation & Compliance Issues – Ensuring all documents met FDA’s eCTD specifications and passing validation checks.
- Tight Deadlines – The client needed to submit the IND within six weeks to avoid project delays.
Our Approach & Solution
The submission required multiple modules, including preclinical and CMC (Chemistry, Manufacturing, and Controls) data.
eCTD Planning & Strategy:
eCTD Planning & Strategy:We developed an eCTD roadmap aligning with the FDA’s requirements for IND submissions.
Defined a clear timeline for document preparation, formatting, and validation.
Document Formatting & Compilation :
- Converted all submission documents (protocols, investigator brochures, preclinical reports, CMC data) into eCTD-compliant PDFs.
- Ensured proper bookmarking, hyperlinking, and metadata indexing for seamless navigation.
Validation & Quality Control :
- Conducted multiple validation checks using eCTD validation tools to ensure an error-free submission.
- Resolved file naming convention issues, hyperlink errors, and missing data to maintain compliance and accuracy.
Final Submission & FDA Interaction:
- Successfully submitted the IND application via the FDA Electronic Submissions Gateway (ESG).
- Assisted the client in responding to FDA technical queries and addressing requests for additional information.
Results & Impact :
IND Accepted on First Submission – No technical rejections or compliance issues. 30% Faster Review Process – Due to well-structured eCTD submission. Successful FDA Clearance – The client proceeded to Phase 1 clinical trials as planned. Long-Term eCTD Compliance – Established best practices for future regulatory submissions.
Conclusion :
Transitioning to eCTD for IND submissions can be challenging, but with the right expertise, it becomes a seamless process. Our experience in regulatory affairs and eCTD publishing helped this biopharma company achieve a smooth and timely IND submission, ensuring compliance and approval from the FDA.