With Harald Studer
The core of Optimeyes was successfully validated
The Features in an Overview
With one click the current market coverage can be displayed in REGULA™. You can check which products are sold in which country and when submissions expire.
In REGULA™ all pending submissions can be displayed with one click. You can check which dossiers are in which status (e.g. in preparation at RA, or sent to local representative etc.) and which dossiers are still missing documents.
REGULA™ automatically alerts about submissions and documents that are expiring. REGULA™ also alerts about submissions that are in the same status for too long (e.g. longer than 30 days “in preparation at QM”). The warnings are sent automatically by pushed email reports to a defined public or can be enquired in REGULA. User-defined warning periods can be assigned for each country and status (e.g. a 120 day pre-warning time for Japan, Belgium only 30 days etc.).
If a submission expires soon, it is re-registered with REGULA™ timely with just one click. On the basis of the old submission REGULA™ creates a new submission folder. Documents from the original submission can be transferred, deleted or replaced by a new version.
Different templates can be created in REGULA™ with the function “Country Templates”. You have the possibility to deposit which documents are necessary, e.g. in Taiwan for the registration of a class IIb Product. For one country several templates can be made. This strongly increases the efficiency of the registration process.
With the elaborated search function, it is possible to search each combination that makes sense, e.g. which documents are used in the submissions of Taiwan, Japan and Korea and was there a change within the last 30 days. The search function has 4 levels and many filter possibilities.
Regularly used and complex research queries from the advanced search can be saved as “Reports”. A report saves the research query and the requested results can be evaluated at any time by one click. The user defines if the saved report becomes visible only for himself or for each person. Each report can be sent by email at a defined public or can be exported as a CSV file.
Information & Comments
Within REGULA™ information and comments can be deposited at any level (country-wide comments, comments on particular submissions, articles, groups or documents). There is also the possibility to update the whole email correspondence. Each comment is marked with a time-stamp and a writer-entry.
The Task Management Tool integrated in REGULA™ allows you to manage simple tasks and assign responsibilities. The tasks can be allocated to Submissions or Documents. There is also the possibility to create a task that is not linked to a specific submission. Each tasks contains specific information like status, such as new, in work and completed, description and due date. Each task is assigned to a REGULA™ User. REGULA™ sends an email warning if the deadline has expired and sets the task to red.
Within REGULA™ you can create templates for indexes, e.g. after STED (Summary Technical Documentation). Different chapters can be defined where the relevant documents are attached.
The submission dossiers can be completed with one click according to these index templates. REGULA™ compiles all relevant documents and summarizes them in a ZIP-File. REGULA™ also generates a PDF index which is included in the ZIP file. The user can decide if the ZIP file should be created flat or with subchapters (e.g. for Canada).
REGULA™ offers the possibility to display all RA activities graphically on an interactive world map. This map gives an overview about the current situation and helps in compiling reports to the management.
REGULA™ has a rights management for users e.g. “Editor”, “Super Editor” or “Administrator”. The rights management can be adapted individually.