The Features in an Overview
Market Coverage
Pending Submissions
Warnings
Country Templates
Advanced Search
Saved Reports
Information & Comments
Submission Indexes
Generate ZIP-File
Worldmap
Rights Management
Market Coverage
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.

Pending Submissions
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.

Warnings
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.).

Country Templates
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.

Advanced Search
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.

Saved Reports
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.

Submission Indexes
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.

Generate ZIP-File
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).

Worldmap
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.

Rights Management
REGULA™ has a rights management for users e.g. “Editor”, “Super Editor” or “Administrator”. The rights management can be adapted individually.

