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Regulatory

July 15, 2021

Schlafender Hase Team

Four Tips for Regulatory Affairs to Proofread Braille

If you are part of a Labelling, Packaging, Graphics or Regulatory Affairs Department, these four tips will save time, and reduce risk and stress due to a missed error – even if you don’t have access to software capable of reading Braille. Since some European regulatory bodies mandate important information such as product name and dosage be written in Braille on packaging, knowing how to ensure Braille accuracy will be an asset for you and your specific life sciences company.

June 20, 2021

Schlafender Hase Team

Biomapas – Providing Top Notch Services to Clients with TVT

Biomapas knew what they were looking for in a proofreading software based on the most common types of files they had to inspect: artwork, application forms, submissions and product information.

March 18, 2021

Schlafender Hase Team

Novo Nordisk – 15 Years of Higher Quality, Increased Output and Improved Efficiency at a Reduced Cost

Novo Nordisk brought its list of requirements to Schlafender Hase. After the two companies worked closely together to ensure that these requirements could be met, Novo Nordisk implemented TVT in 2005.

March 16, 2021

Schlafender Hase Team

The EMA and TVT

This may come as a surprise to regulatory affairs professionals of the pharmaceutical industry, but the European Medicines Agency (EMA) has been using TVT, the Text Verification Tool® since 2004!

February 16, 2021

Schlafender Hase Team

Future-Proof Your Regulatory Submissions – Increasing Efficiency and Quality With Information Management Systems

Information and data management is an integral part of regulatory compliance across the globe, particularly in the highly regulated pharmaceuticals and medical device industries. These systems support industry by providing highly specialized as well as essential services. Companies benefit from these by being able to develop harmonious strategies and systems that evolve as regulations change. Whether you are currently using information management systems or just setting out, there are some key aspects you need to consider if you want to get it right. This will also be the topic of an upcoming webinar on 23 February 2021.

November 19, 2020

Schlafender Hase Team

Schlafender Hase’s TVT® Now Integrated with Esko WebCenter 20

Mr. Hessler stressed, “The integration of TVT with WebCenter 20 connects two companies that both aim to combine efficiency, simplicity and quality to give customers competitive advantages.” Schlafender Hase is convinced that the qualities that make TVT the leader in the rigorous pharma industry can also make TVT a leader in other industries like fast-moving consumer goods (FMCG) and consumer product goods (CPG).

September 16, 2020

Schlafender Hase Team

Lohmann & Rauscher – More Output, Less Resources

The return on investment was clear and rapid. “Errors were recognized quickly, and the number of correction cycles was significantly reduced,” said Michael Breiler, Lohmann & Rauscher’s Director of Packaging Development.

December 17, 2019

Schlafender Hase Team

The European Medicines Agency (EMA) Doubles User Licenses for TVT®, the Text Verification Tool®

Schlafender Hase has announced that the European Medicines Agency (EMA) is doubling the number of user licenses for TVT®, the Text Verification Tool®. EMA has been using Schlafender Hase’s TVT for 15 years.

October 20, 2017

Schlafender Hase Team

Adapt to Survive

No market is immune to change, and life sciences continues to face its fair share of upheaval as the industry accommodates emerging innovation in healthcare and a raft of other challenges to the status quo. Below are five of the most prominent trends and what they mean in practice.

September 27, 2017

Schlafender Hase Team

Form and Substance

One practical way to get ahead is to harness automation in the preparation of data by identifying and selecting the definitive source documents; checking for updates; and aligning languages, fonts and other intricacies. Sophisticated tools are available that reliably and precisely compare files in different formats for the possible information they contain. This ability to quickly contrast content of similar documents from multiple sources in large batches could help save firms vast amounts of time in this substantial preparatory stage of getting the company’s product data assets in order.