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In today's highly regulated pharmaceutical industry, ensuring compliance with electronic Common Technical Document (eCTD) publishing and electronic filing is crucial for market entry in both the US and EU. For small-to-mid-sized companies, navigating these complexities can be daunting, but with the right approach, it can be a manageable process. In this blog, we will outline the preliminary stages that small-to-mid-sized companies must take to ensure a smoother eCTD publishing and electronic filing process for market entry in the US and EU.
Ensure the Right People, Processes, and Technology
The first step in ensuring a successful eCTD publishing and electronic filing process is to ensure that the right people, processes, and technology are in place. This involves:
- Coordinating Across Functional Areas: Regulatory, IT, and document management teams must work together seamlessly to ensure that all necessary documents are prepared and submitted correctly.
- Investing in eCTD Publishing Software: Companies can either invest in eCTD publishing software or partner with a regulatory services provider to ensure compliance with the current eCTD Submission Standards.
- Obtaining Training: It is essential to obtain training on the current eCTD Submission Standards and local/global regulations to avoid common pitfalls and ensure compliance.
Familiarize Yourself with Technical Requirements
Understanding the technical requirements for eCTD publishing is crucial for a successful submission. This includes:
- Comprehensive Table of Contents Headings and Hierarchy: Companies must ensure that their documents adhere to the detailed formatting specifications outlined in the eCTD Submission Standards.
- Detailed Formatting Specifications: Companies must adhere to detailed formatting specifications, hyperlinking, metadata, and naming conventions to ensure compliance.
- Common Reasons for Submission Rejections: Companies must be aware of common reasons for eCTD submission rejections by regulatory agencies to avoid costly delays.
Establish a Document Management and Publishing Process
Establishing a document management and publishing process is critical for ensuring compliance with eCTD publishing requirements. This involves:
- Developing and Distributing Style Guides and Templates: Companies must develop and distribute style guides and templates to ensure consistent formatting across all documents.
- Implementing Procedures for Providing Metadata: Companies must implement procedures to provide all necessary metadata and information to publishers.
- Thoroughly Testing Source Files: Companies must thoroughly test source files in the publishing software before final submission to ensure that all documents are accurate and compliant.
Leverage Industry Best Practices and Learn from Common Pitfalls
Leveraging industry best practices and learning from common pitfalls can help small-to-mid-sized companies avoid costly delays and ensure compliance with eCTD publishing requirements. This includes:
- Obtaining Advice from Experienced Industry Experts: Companies can obtain advice on eCTD publishing from experienced industry experts to ensure that they are following best practices.
- Understanding the Reviewer's Perspective: Companies must understand the reviewer's perspective and common submission issues to ensure that their submissions are compliant and complete.
- Conducting Practical Workshops and Case Studies: Companies can conduct practical workshops and case studies to build eCTD publishing expertise and avoid common pitfalls.
Conclusion
In conclusion, ensuring compliance with eCTD publishing and electronic filing is crucial for market entry in both the US and EU. By following the preliminary stages outlined in this blog, small-to-mid-sized companies can better navigate the complexities of eCTD publishing and electronic filing, leading to a smoother market entry process.
Author: Sonal Gadekar
