FRANKFURT AM MAIN, Germany, March 19, 2014 /PRNewswire/ --
A Simple Way to Accelerate and Simplify the Management of Marketing Authorizations
Today the pharma industry is under tremendous pressure. Healthcare drug budgets are being reduced. The costs of bringing a new drug to market are spiralling, and there are serious legal obligations in keeping up with an ever more complex regulatory environment.
To maintain profit margins, companies are looking to increase their efficiency by transforming repetitive and labor-intensive manual workflows into automated ones; a pattern known as lean process. In the pharmaceuticals sector, the processes related to acquiring and maintaining marketing authorizations hold huge potential for improvement.
The solution: LORENZ Automator
LORENZ Automator transforms common manual workflows in the regulatory affairs arena into efficient, automated and documented ones. The product contains a set of scripts/toolkits covering all common post-publishing activities such as validating submissions, sending to a gateway, importing to a submission management system, sending replies. These functions can be flexibly mixed and matched to suit each customer's specific business needs. Both industry players and approval authorities can extract huge benefits from the product.
Accuracy and efficiency for industry
For industry, LORENZ Automator can take an internally published and approved submission and validate it, before preparing the message and signing it in line with requirements of the relevant gateway and then sending it using the LORENZ eSubmission Gateway. The eSubmission Gateway waits for the agency response, receives it and then updates the status in the Automator's webPanel.
Reduced formatting errors
Automator offers a Corrective Profiles function that will re-render files to meet ICH regulations on hyperlink formatting, opening settings, and attachments. Even files delivered at the last minute by other service providers can be integrated seamlessly into an eSubmission without technical errors. This function also assists employees who may be unsure how to actually resolve the issues reported by a validator.
Simplified workflow for Authorities
Authorities can schedule LORENZ Automator to run at regular intervals to check any central repository for new submissions, or can be triggered directly from the gateway. It can then download the submission, detect the format (eCTD, NeeS, or other) and optionally perform a validation before importing and attributing it based on information from the gateway or on information in the eCTD itself. Customers working with LORENZ docuBridge can import the submissions automatically. Other submission, workflow and tracking systems can also be included in the workflow.
In fact, since August 2013, the German approval authority BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte) no longer requires original signature pages or a CD/DVD copy of new submissions that are made via the CESP gateway in either eCTD or NeeS format. LORENZ Automator is a factor in enabling this simplification.
Monitor, control and integrate with your own CMS
Automator's integrated webPanel enables users to keep an overview of the selected processes, and to see all the reports created in each run. Automator can also inform users that submissions are complete and when responses have been received. The entire information flow can be seamlessly integrated with submission, workflow and tracking systems in the customer environment.
Learn more about the Automator and visit LORENZ at the DIA Euromeeting
Our staff will be on hand throughout the 2014 DIA Euromeeting, being held in Vienna from 25-27 March. Feel free to drop by for a demonstration of LORENZ Automator at booth X714.
If you are not planning to be at DIA and would like a demonstration, please contact LORENZ at http://www.lorenz.cc/email.
LORENZ Life Sciences Group (http://www.lorenz.cc) has been developing and marketing software solutions for the Life Sciences market since 1989. LORENZ's solutions are geared specifically for submission assembly, review, publishing, validation and management. LORENZ docuBridge® is the most widely used eCTD submission management system for U.S., European and Japanese formats among many others, and is popular with regulatory agencies and industry alike. With over 300 installations in over 25 countries, LORENZ has a strong worldwide customer base.
Petra Mc Grath
E-Mail: [email protected]
SOURCE LORENZ Life Science Group