The transition from NeeS to eCTD

Introduction & overview

The regulatory landscape, including pharma regulatory affairs, has faced major revolution and transformation by adopting the eCTD format across the globe. Electronic submissions are driving efficient product authorizations and approvals for pharmaceutical organizations to stay ahead of the market. Undoubtedly, these benefits of eCTD are enormous- particularly the fact that the eCTD format reduces the time and resources needed for regulatory submissions. Furthermore, it provides enhance management and tracking of the necessary regulatory information while maintaining compliance. But the transition from paper-based submissions to NeeS to eCTD is not as straightforward as it seems as it is associated with many challenges regarding added cost, resources, and time. 

Transition to the eCTD

One of the main challenges that regulatory professionals face when transitioning to the eCTD is the time and resource it takes. For example, organizations would need to invest in software, staff, and additionally resources. Training and education on the new format will also be needed.

Some regulatory solutions to ensure a successful transition include understanding and including all key stakeholders in the process. This could be regulatory affairs and IT teams among other departments. Companies should also make sure they invest in the training and education of employees which can vary from in-house to online training sessions.

Pharmaceutical organizations that incorporate software and IT systems to support this transition are 2 steps ahead in the game. Many software provide solutions to companies for them to manage their eCTD submissions in a more efficient manner while ensure they maintain compliance. This can include automation of submission and publishing tasks which significantly reduces time, errors, and any discrepancies.  

Partnering with eCTD vendors and industry expertise

One on hand, pharma organizations are encouraged to build, develop, and upgrade their regulatory submission functions. Another option, and a more cost-effective & resource-alleviating one, is to outsource submissions to regulatory consulting organizations and regulatory service providers that have decades of experience and the technological platform to manage submission on behalf of pharma organizations. Indeed, this means that these organizations can spend more time on other operations and tasks that would bring greater business-added-value and ROI.

Regulatory service providers and consulting teams that leverage their smart-tech platforms with their subject matter expertise and regulatory intelligence are at the forefront of the pharma industry. Not only are they aware of some of the industry knowledge and updates, but they are also equipped to handle any obstacles that may emerge. 

Conclusion

Indeed, efficient regulatory submissions in the eCTD format improve the communication between regulatory agencies and pharma organizations such as MAHs and sponsors by creating a standard and harmonized format. Partnering with the right strategic industry expert can help pharma organizations remain ahead of the regulatory landscape and competition by ensure faster, accurate, and more efficient product approval. 


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