Identify the best suited software ahead of time
With an aim to grab the maximum market share, drug manufacturers (innovators/generics) may sometimes wish to market their products, across the globe, which have already got approvals in one region. However, following a single regulatory approach for all the regions is almost a difficult task and perhaps not advisable. Therefore, the need of the hour is to implement a highly scalable and flexible submission solution that harmonizes the documents to be submitted in targeted countries. This write up will help you decide on a robust software that fulfills the ever-evolving regulatory requirements for the streamlined submission procedures across (regions).
Let’s see the numbers first. Did you know for a company that submits just 100 documents per week, automating the process can save 183 man-hours per week or $572,000 per year (based on a salary of $60 per hour). In these scenarios, the harmonization of information and document workflows plays an important role. Although companies are now implementing automated enterprise information management systems to monitor eCTD submission documents, meeting the regulatory requirements remain a challenge when it comes to multiple geographies. A lot of companies end up spending heavily on already approved drugs in a new region especially to ensure compliance and final document quality checks. Is there a simple solution that can help companies, save the inordinate amount of time and resources to go global with an already approved drug? We say, Yes. How to find one? Let’s explore what companies need to consider when selecting a robust software solution to drive the eCTD lifecycle.
Quality Wins the Spat
A software that promises best in class document rendering quality helps companies save resources required to assess and update every document as per the regional submission. Once a document has been analyzed thoroughly, the rework on QC activities is saved.
Compliance Readiness
Regulatory compliance strategy and document conversion implementation should go hand in hand. Although there are several applications in the market for eCTD conversion, but not all of these focus on compliance readiness approach.
Reusability
One approved drug, multiple common documents, and different geographies. These need to align better to avoid replication or rework. There are lot of segments that can be reused in a new geography depending on the regulatory requirements. Is your software efficient enough to segregate similar or common documents for the submission in a new region? If not, this is another feature that can help save manual efforts to identify common areas of the submission.
Integration on the Go
Where there is harmonization or synchronization of information involved, well-run integration is inevitable. Possibility of errors during final incorporation should be the last thing on your list to worry about. Get a system that employs open protocols and standards like web services and XML that can effortlessly fit right into your existing set-up.
Scalability
The submission demands in pharmaceutical and life sciences companies are never ending now. Everyone in the game wishes to get through it with heavy volumes of data in multiple geographies. The solution should have the capability to meet the requirements of high volumes without compromising on the quality of the submissions.
User-friendly Workflow
There is no doubt that streamlining submissions in multiple geographies is majorly carried out by a technology driven solution. However, companies should make sure that the tools involved are not intricate to get hands on. It should be simple, flexible, and efficient.
In Conclusion
Features such as scalable conversions, OCR capability, and a wide-ranging rendering structure is what drives smooth submissions in multiple countries. In fact solutions with these features not only help in harmonization of submission and publishing processes but on a bigger platform, helps enterprises to leverage these benefits in other frameworks too. eCTD solution that supports emerging markets’ submission requirements and offer advanced features to efficiently manage the entire eCTD lifecycle is what calls for the need of the hour.
