August 8, 2022
eCTD Submissions and Regulatory Development Strategies

Over the years, procedures for assembling and filing eCTD submissions have evolved tremendously. Non-adherence to the submission requirements may occur when documents are not relevant to fit seamlessly into the given eCTD format. In such scenarios, applicants are burdened with making last-minute amendments, which cause a delay in submission or, in an extreme case, a technical rejection of the entire submission.

Drafting an electronic Common Technical Document (eCTD) application requires applicants to develop strategies from the offset, conduct pre-submission meetings with Agencies, and seek their advice on essential data. Stringent quality assurance for Regulatory compliance frameworks while considering drugs and biologics should be implemented in the early stages. A checklist needs to be secured in place to assure the operability of such a framework of strategies.

Strategies to Prevent Regulatory Submission Mishaps

Source Document with Publishing Software

Setting up source files compatible with the publishing software optimizes the application approval process. For any of the functions conducted externally, organizations must:

  • Establish standardized procedures, templates, and forms for external service providers
  • Provide documents with specifications and expectations associated with source files to the Agency
  • Always ensure the source files are tested in the publishing software well before the final publishing is scheduled

Rational Information for Publishers

eCTD submissions depend on the use of metadata for additional information. Providing the publishers with critical information along with the source files eliminates potential rework. Transparency allows publishers to interpret the information provided correctly and prevents errors.

Submission of Accurate Document Version

Experts utilizing closed Document Management Systems (DMS) in their publishing workflows avoid wrong document version problems, as only those documents and/or versions marked as approved are available for publishing. Groups that use file shares for publishing repositories are more susceptible to this type of problem and, therefore, require far more stringent procedures.

Technical Problems with Legacy Files

The software that is not updated as per the new versions can lead to errors. eCTD highlights technical issues efficiently when it comes to legacy files successfully printed in the past. Addressing the issues well in advance can avoid delays and save time and cost.

Automated PDF

Using an automated PDF rendering system enhances the efficiency of compliance for Regulatory submission. Once documents are uploaded with the content required for submission, systems can automatically render content into multiple versions of PDFs that meet the respective Health Authority (HA) requirements. The system also supports such a way by creating multiple versions upon new updates, coloring hyperlinks, bookmarking figures and tables, adding tables of contents upon exceeding the specified number of pages, highlighting the extra content, and optimizing for fast web viewing.

Speculations Prior to Submission

  • Validate Regulatory requirements for every subsequent submission. Health Authorities publish new eCTD versions over time.
  • Create a compelling narrative for the drug product backed by scientific data.
  • Develop a roadmap to manage multiple documents beforehand with the help of pre-defined templates.
  • Assess the product information with the help of SMEs.

Conclusion

A combination of strategic experience and knowledge in Regulatory submissions ensures Chemistry, Manufacturing, and Control (CMC) practices are managed per the requirements of HAs. To avoid last-minute changes, the preparation of eCTD applications requires proper planning, organization, and resources. At Freyr, our experts can help you navigate the eCTD submission approval process in a well-organized manner, making submissions easier for the FDA to review. Consult Freyr for error-free and cost-effective submissions. Global eCTD Publishing and Submission Services

Author:

Sonal Gadekar
Associate