Why to outsource your eCTD services?

23/05/2024

The Electronic Common Technical Document (eCTD) is a standardized format for submitting regulatory documents electronically to health authorities. It was developed to optimize and harmonize the submission process for pharmaceutical products, facilitating more efficient reviews and approvals.

What is eCTD?

The eCTD format organizes submission documents into a hierarchical structure consisting of five modules:

• Module 1: Regional Administrative Information (specific to the region where the application is submitted)
• Module 2: Common Technical Document Summaries (overall summaries of quality, safety, and efficacy)
• Module 3: Quality (detailed information on the quality of the drug substance and drug product)
• Module 4: Nonclinical Study Reports (studies on the pharmacology, pharmacokinetics, and toxicology of the product)
• Module 5: Clinical Study Reports (data from clinical trials on the product’s efficacy and safety)

The standardized format ensures that all submissions meet regulatory requirements and are presented consistently, enhancing the quality and reliability of the information provided.

Challenges in eCTD Submissions

Establishing eCTD services in-house is a time-consuming and complex process. eCTD compilation requires specialized training and expertise. Personnel must be thoroughly trained in using the software and understanding the regulatory requirements. This includes a significant time investment in training personnel. In the eCTD sequence, all documents must be properly formatted to comply with eCTD granularity requirements. It is crucial, as even small mistakes in formatting or document structure can result in the rejection of the submission, leading to significant delays and additional costs.

Moreover, creating and managing eCTD sequences demand the use of specialized software. This software facilitates the assembly of documents into the precise hierarchical structure required by health authorities. Validation tools are also essential for checking technical compliance and identifying any issues that could lead to delays or rejections.

Companies must also evaluate whether they have enough human resources to handle eCTD submissions internally. For companies with a smaller number of applications, managing this process in-house can be particularly challenging and may not justify the investment required for process setup, trainings, software licenses, and ongoing maintenance.

Outsourcing eCTD Services: A Strategic Solution

Given these challenges, many pharmaceutical companies find it more beneficial to outsource eCTD services to external experts. By doing so, they can use the regulatory expertise without the need to manage specialized software themselves. Outsourcing ensures that submissions are handled by professionals with extensive experience, minimizing the risk of errors and enhancing the chances of timely regulatory submissions and approvals.

Outsourcing eCTD services can also save time and costs associated with personnel training. Besides that, companies need to evaluate if they have enough human resources who can handle the eCTD process effectively. For companies that have a smaller number of applications, in-house eCTD compilation can be costly, making outsourcing a more efficient option.

Moreover, outsourcing is a faster solution than implementing the process in-house. Companies should evaluate when their first eCTD sequence is needed to determine if they have sufficient time to set up the process internally or if outsourcing would be a more timely and effective solution.

At Biocodex PhaMe, we offer a wide range of regulatory services, including comprehensive eCTD compilation and submission support. Our experienced professionals ensure accurate and timely submissions, minimizing risks and maximizing your chances of regulatory approval. Contact us today to learn more about how our services can support you in your regulatory processes and contribute to the success of your business.