Here we are in 2018, and to the surprise of some and the consternation of many, some paper applications are still alive and well. However, their days are numbered. The May 5, 2018 FDA eCTD mandate deadline is upon us. Is your company prepared to implement the FDA’s regulations for eCTD submissions of INDs, NDAs and DMFs?
Take Action to Meet the FDA eCTD Mandate Deadline
For companies who have not yet made the switch to eCTD, it’s time to take action. Whether your company prepares eCTD submissions in-house or plans to outsource them, your solutions must be in place. The next few months will go by faster than you expect.
If bringing eCTD publishing in house is your choice, you’ll need to consider several things. You’ll need appropriately trained staff on the payroll, and you’ll need eCTD publishing software. The time it takes to implement, validate, and train is also a major commitment. Finally, you’ll need to consider broader, organizational changes, such as drafting new SOPs, training your authors to create eCTD submission-ready documents, and making use of eCTD templates and authoring tools.
If an outsourced eCTD submission model is more practical, you’ll need to develop an RFP and solicit proposals from qualified vendors. The evaluation and selection process for outsourcing partners can be just as time consuming as that for purchasing software. You’ll want the time to move deliberately to ensure that you select a vendor with the right mix of technical competency, customer service, and cultural fit with your organization. Even if you plan to outsource, you will still also need to invest time and resources in things like new or revised SOPs and training for your team.
Synchrogenix Can Help
Synchrogenix’s team of publishers brings over ten years’ experience in helping to convert clients from paper to electronic format.
We provide personal attention to our clients through dedicated publishing teams, yet are scalable to accommodate needs as necessary, without sacrificing quality or our transparent and consistent pricing integrity. Our software and AI-enabled technology allows us to perform actions at faster rates while achieving greater quality. Additionally, our regulatory and writing experts can provide other offerings as needed such as Regulatory Strategy, Affairs, and Authoring to ensure project success.
So if you’re not prepared for the May FDA eCTD Mandate, contact us today.
While transitions can be difficult, experienced partners, such as Synchrogenix can help fill the knowledge gaps and share industry best practices, while also helping you achieve submission success simply, quickly, and cost-effectively.
To learn more about Synchrogenix’s regulatory operations and publishing solutions, attend an upcoming event or webinar.