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eCTD Software Consulting


Hiring an experienced eCTD regulatory consultant is a great method of capturing the expertise needed to help your company make a successful transition to regulatory-compliant eCTD submissions.

Some may argue that a more cost-effective approach would be an initial investment in introductory eCTD Regulatory training. While this may be true, one-on-one sessions with a regulatory consultant can provide targeted advice that is specific to your company's needs. Even the best eCTD training program will not be able to provide your staff with everything that they need to know in order to begin preparing your regulatory submissions in eCTD format. Furthermore, after a seminar a training instructor will not be available to answer new questions as they arise (and they will).

eCTD Readiness Assessment

In the first stages of your transition, quality regulatory consulting can help you with an initial eCTD readiness assessment and identify aspects of your business processes and/or infrastructure that may need to be modified. While regulatory training may demonstrate how to perform one, a consultant can do it for you.

A regulatory consultant can also help you choose the right eCTD software package for your company. Information obtained from a readiness assessment can be very helpful in determing your software options. For example, a software package that appears to be both cost-effective and perfect for your eCTD submission needs may require significant modification of your information technology infrastructure if your company uses an incompatible database system.

We thought we had found the perfect eCTD software provider. Fortunately, we decided to seek input from our IT deparment before signing the contract.

As it turns out, this software package needed to be run on a server with an Oracle Database platform - a conversion that itself would have costed us roughly $50k.


Your first eCTD submissions

You have done everything right: you sent your staff to a quality, hands-on eCTD training seminar; you hired a regulatory consultant to perform an eCTD readiness assessment and help you choose your package of eCTD software and tools; and you completed the week of training that you remembered to include in your eCTD software contract. Even with as much confidence as you may have in your new Regulatory abilities, preparing your first eCTD submissions (including your demo and/or pilot submissions if you are submitting to FDA) will probably be quite overwhelming. A regulatory consultant will be able to provide guidance and reduce frustration, helping to keep your staff productive and happy during their transition.

Improving your eCTD processes and maintaining regulatory compliance:

Whether or not you decide to invest in regulatory consulting prior to your transition to eCTD submissions, you will likely get a great return on your investment if you decide to utilitze one at some point in your development with eCTD submissions.

Aside from being able to answer specific questions that you may have regarding your eCTD software, an eCTD consultant can also help your company stay current with the changing regulatory requirements (e.g., FDA, EMEA, ICH), improve the efficiency of your eCTD processes, and provide expert advice to help with your marketing applications and getting drug products on the market. Not to mention the regulatory consulting they will be able to provide during regulatory compliance audits.

 

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