eCTDs for example are subject to change, and their continuous evolutions are promoting discussion in areas and initiatives such as RPS (Regulatory Product Submission). Companies focusing their efforts on "eCTD Tools" however may well find that they will need to re-invest - or possibly make drastic changes - every time a new standard is announced. This has already been witnessed with the move from the eNDA to the eCTD with the FDA - spurring new systems, new validation, new training and naturally, new costs.
The challenge for any Regulatory Affairs professional is to find a solution which will embrace current and future standards.
Companies should search for solutions that are fastest-in-class in terms of adherance to changing regulatory requirements. Through the use of scripting technology the right solution should also be able to update most of the regulatory changes that naturally occur through new control files rather than relying on software coding changes. This increases the speed with which customers can be up-to-date, and significantly reduces validation needs.
Rather than focus on an output that is subject to change, Regulatory Affairs professionals may want to concentrate on their submissions needs with the business process in mind. This means designing a system from beginning to end, not from end to beginning.
To learn more about an eCTD solution that updates regulatory changes via control files rather than relying on software coding changes, please feel free to contact a LORENZ representative.