The world's leading automated proofreading software

Regulatory

January 17, 2024

Schlafender Hase Team

TOPRA Sponsored Webcast: A Non-Technical AI Introduction for Regulatory Affairs Professionals

AI is already being used in many Life Science applications, meanwhile Health Authorities are looking to regulate the use of AI. As a regulatory affair professional, it is essential to have an understanding of this technology.    In this general introduction to the field of AI, different uses of the term "Artificial Intelligence" will be discussed, and which might be desirable in a given context. 

October 16, 2023

Schlafender Hase Team

How To Ensure Your Labels Are Always Compliant

Labeling compliance is important. Find out why, and discover how you can ensure your product labeling is compliant with regulations for pharmaceutical and food products.

October 2, 2023

Schlafender Hase Team

9 Reasons Proofreading in Life Sciences Can Be a Nightmare

Risks, stress and more – there’s a lot at stake when you proofread in regulated industries. Here are nine reasons why.

September 15, 2023

Schlafender Hase Team

A Guide to Purchasing Proofreading Software for Regulated Industries

Have you identified the need for a solution to compare text and graphics in your organization, but need some help with the complete process of identifying, evaluating, and acquiring the right solution?

August 23, 2023

Schlafender Hase Team

How to Build a Business Case for Document Comparison Software: A Step-by-Step Buyer’s Guide

Join Schlafender Hase on September 14th, as we guide you through the typical steps needed to properly identify the right tool for your organization and how to get it approved.

July 31, 2023

Schlafender Hase Team

Maximizing the benefits of e-labeling in Pharma and Med Device

With electronic labeling gaining momentum across healthcare markets, are you ready to maximize the benefits?

June 28, 2023

Schlafender Hase Team

5 Ways a Proofreading Software will Keep your Regulatory Affairs Team Happy

Proofreading documents manually in regulatory affairs (RA) in the life sciences industry is stressful, high-risk and can lead to job dissatisfaction. The stakes are high – errors can harm patient health, result in product recalls, and damage brand and company reputations. Here’s how TVT, the proofreading software for regulatory affairs, can keep an RA team happy.

May 23, 2023

Schlafender Hase Team

Regulatory Guidelines for Labeling in Pharma

Pharmaceutical labeling is a critical element of healthcare products and services that are strictly regulated by health authorities. This includes the Food and Drug Administration (FDA) in the United States and the European Medicines Agency (EMA) in Europe. The FDA oversees the safety and efficacy of pharmaceutical drugs, biopharmaceuticals, and other healthcare products. As a result, pharmaceutical labeling is a complex and meticulous process, with even minor errors resulting in significant consequences.

May 8, 2023

Schlafender Hase Team

Regulatory Affairs – Partnering for Knowledge

As a company that was built around a specific need for Regulatory Affairs (RA), we must also remain on top of regulatory developments. Ensuring our software continues to meet the needs of RA professionals. Our top resource is RAPS, the Regulatory Affairs Professionals Society and in this article we look at our partnership with RAPS and the importance of this organization.  

March 16, 2023

Schlafender Hase Team

Digital Transformation of Medical Device Labelling: A Practical Guide

By allowing medical device suppliers to provide up-to-date, reliable product and safety information in a secure and accessible format, e-labelling has the potential to revolutionise how medical professionals and patients access and manage information. In this article, Peter Muller of Schlafender Hase examines the potential of e-labelling and recommends practical steps to secure the benefits of e-labelling.