Author Archives: llsmarketing

docuBridge FIVE 5.11, docuBridge TWO 1.0, docuBridge ONE 2.4, drugTrack 5.3 and eValidator 5.10 released!

The October releases of docuBridge, drugTrack and eValidator are available!

Release Highlights:

With this release we are introducing docuBridge TWO, an addition to the docuBridge range geared specifically to small- to mid-sized companies with multiple users.

Continue reading

UPDATE: Current State of US FDA’s Electronic Common Technical Document (eCTD) Validation and Review Software Procurement and Implementation

We would like to provide our customers and the industry with an update on the status of LORENZ’ implementation of LORENZ docuBridge, eValidator, and Automator at the U.S. Food and Drug Administration (FDA).

(Please click here to read our previous blogpost including a timeline of events from 1 July 2016 – 30 May 2017.)

Continue reading

International Trends in Drug Registration and Evaluation [Part 1: eCTD v3.2.2]

Today Jared Lantzy, Manager Global Regulatory Agencies and Processes at LORENZ, starts with a series of articles talking about international trends in Drug Registration and Evaluation. He will provide an update on some selected topics in electronic submissions and some insight into how LORENZ will deal with these evolving regulatory requirements.

Introduction
Regulatory authorities around the world continue to adopt internationally recognized data standards in an effort to improve the efficiency of their work environments and processes. The most commonly discussed data standards are the Electronic Common Technical Document (eCTD); International Organization for Standardization (ISO) Identification of Medicinal Products (IDMP); Health Level 7 (HL7) Structured Product Labeling (SPL)-based standards for the transmission of product data, including IDMP; and Clinical Data Interchange Standards Consortium (CDISC)-based standards for both clinical and non-clinical study data.

Continue reading

userBridge.17 in Nice, France from 19-21 September 2017: Save the date and register now!

Our annual community conference LORENZ userBridge is well-known for showcasing the very latest thinking from the world of regulatory affairs, with high-level speakers recruited to give a wide range of expert perspectives from industry, agencies and consultants.

A variety of agency and industry players will be sharing their experiences at userBridge.17. Please see the preliminary agenda for more details.

We look forward to welcoming you to Nice!

Current State of US FDA’s Electronic Common Technical Document (eCTD) Validation and Review Software Procurement and Implementation

We at LORENZ have been receiving an increasing number of emails and phone calls from our customers and partners concerning the current state of the project implementing LORENZ docuBridge, eValidator, and Automator at the U.S. Food and Drug Administration (FDA).

In order to clarify the chain of events and alleviate any concerns, we are outlining below a timeline of events we hope will be helpful.

Continue reading