Solutions for Regulatory Affairs professionals
Regulatory Affairs professionals are increasingly under pressure to handle ever more information in less time to stricter standards. Regulations are changing more often and global standards take time to be implemented – the eCTD being one of the more significant examples. In additional, increased pressure of being able to handle the global market more quickly via new technologies adds to the picture of daily tasks to be conquered.
On the other hand, supporting applications are slow to establish themselves and the use of spread sheets still seems to a “solution” for many to manage information. The fact that this process increases the risks of non-compliance, manual mistakes during data entry and therefore the submission of incomplete or even worse incorrect data is a well-known phenomenon. Recent statistics from the EMA about the quality of EVMPD data submitted by a variety of applicants underlines the true problem and additional corrective effort required, never mind possible impact to patients.
Being able to deliver accurate data in time is becoming a necessity to Regulatory professionals who want to survive the next wave of “big data”.
Fortunately, this is where Samarind RMS can help. Reducing the time for implementation via pre-defined validation packages, minimising the time out for training via the supply of a single easy to use interface and providing all required information from the Single Point of Truth allows the Regulatory professional to concentrate on the task in hand rather than spending time on technology.
Using Samarind RMS gives you the necessary tools to manage the entire medicinal product life cycle without having to enter information twice. Following the Emerging Dossier Concept, information available during the early stages of product management can be entered ahead of time, allowing faster review and approval at the later stages when time is usually tight. Faster reaction to change, easier data management and time saved via single data entry all helps the Regulatory professional to make the most of the information available.
Samarind RMS will assist the Regulatory professional with all of the above.
- Product information will be entered once and shared via a single repository
- Variations can be managed and tracked globally but owned locally
- eCTDs can be created reusing the required meta data
- Business rules support correct EVMPD submissions