Automating The Artwork Review Process

Speed to market is king in the fast-moving world of consumer goods. Yet, countless hours are spent reviewing packaging artwork before going to market. Traditional review methods are time-consuming and prone to human error. A single mistake in an ingredient list or a barcode could result in lost sales or shelf space, a recall and damage to the brand reputation.

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Navigating FDA Guidelines for Pharmaceutical Packaging: A Focus on Packaging Artwork

Pharmaceutical packaging plays a critical role in ensuring the safety, efficacy, and quality of medications. The US Food and Drug Administration (FDA) closely regulates packaging and labeling, as well as manufacturing processes in pharmaceutical packaging. Ultimately, these regulations and guidelines safeguard patient health.

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Top Regulatory Challenges in Food Labeling and How to Overcome Them

Food labeling plays a crucial role in protecting consumer health by providing information relating to food sources, nutrition and safety. Accurate and informative food labeling allows consumers to make informed dietary choices. Compliance with food labeling regulations is not only a legal requirement but also impacts brand reputation.

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The Future of Patient Information: A Discussion on GI 4.0® with Manuela Wiegand from Rote Liste

The way patients access critical medication information is evolving. In this expert discussion, Philipp Thomas from Schlafender Hase speaks with Manuela Wiegand, pharmacist at Rote Liste® Service GmbH, about Gebrauchsinformation 4.0 (GI 4.0®)—Germany’s move toward digital patient information leaflets.

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Increased Focus on Promotional Compliance – Insights from OPDP and PAAB

In mid-2024, new US Food and Drug Administration (FDA) rules came into force for prescription drug advertising on television and radio. These rules are designed to promote more clarity, [1] and we can also expect future changes affecting social media influencers, especially when promoting weight loss drugs.

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Ensure Compliance with the Latest Cosmetic Trends and Regulations

As cosmetic regulations evolve, maintaining labeling standards is becoming increasingly complex. Here we explore some key changes in cosmetic labeling regulations and highlight how to ensure your products meet all requirements.

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Health Canada’s XML Product Monograph Update: What It Means for Regulatory Teams

Health Canada has announced changes to the filing requirements for Extensible Markup Language (XML) Product Monographs (PMs), signaling a shift toward enhanced digital documentation standards. The first phase of these requirements come into effect on July 18, 2025. These updates will impact regulatory teams, requiring adjustments in their processes to meet the new expectations.

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Med Tech in a Globalized World: Overcoming Regulatory Compliance Challenges for International Success

Despite stakeholders’ efforts to harmonize the medical device industry across regulatory jurisdictions, manufacturers face significant challenges in achieving global regulatory compliance. Gradually, however, we are seeing greater recognition globally of quality standards. In regions beyond Europe and North America, harmonization initiatives are well underway.

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The Future of Labels: Embracing Digital Technology for Enhanced Efficiency

Think back to the early days of labeling – when medicines were sold by salespeople at events resembling circuses more than genuine health events. Consumers often had little to no knowledge of what was inside the medication bottle. In fact, the first US regulation on labeling, introduced in 1906, merely required that any listed contents were truthful.

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8 Trends Shaping the Future of Drug Labeling

Serialization in pharmaceutical packaging and drug labeling is crucial to product safety, regulatory compliance, supply chain efficiency and the fight against counterfeit drugs.

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RAPS Webinar Highlights: Learning the New Language of the EMA & The FDA – FHIR

As the healthcare industry undergoes rapid transformation, it is shifting away from product information (PI) based on physical and unstructured digital formats to electronic data formats offering greater accessibility, interoperability, and potential for global alignment. A key factor in this transformation is the data standard Fast Healthcare Interoperability Resources (FHIR).

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Elevate Your Expertise with TVT e-Learning: Training for Precision and Professional Growth

When you work in a regulated industry where the risk of mistake is high, staying proficient with your tech stack and compliant with evolving standards is essential. With TVT being a cornerstone for many professionals in document review and labeling accuracy, Schlafender Hase has introduced a comprehensive e-Learning portal.

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Introducing TVT 12: A New Era in Compliance and Efficiency

With growing demands on regulatory professionals to ensure accuracy and efficiency, the newest version of the industry-trusted proofreading software, TVT 12 delivers enhancements that allow users to navigate complex document requirements with greater ease and confidence.

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The Road Ahead: Exploring Regulatory Trends Shaping Med Device and Pharma in 2025

The life science industry is poised to undergo significant shifts, driven especially by new technologies in healthcare. Technologies are also driving greater transparency in supply chains. Other features of the industry landscape that we foresee for 2025 are a more globally harmonized regulatory framework.

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Schlafender Hase’s Customer-Led Development Process

Schlafender Hase follows a customer-led development process of continuously incorporating feedback from its users into every TVT upgrade.

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Regulatory Changes and Compliance in the Agrochemical Industry

Agrochemicals are vital for improving farming efficiency. They include key products like pesticides, herbicides, and fertilizers, which help farmers boost crop yields and protect against pests. In order to minimize environmental and health risks, strict regulations govern the agrochemical industry.

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How to Prepare Product Labeling for an EPA Label Review

The U.S. Environmental Protection Agency (EPA) label review process plays a crucial role in ensuring that pesticide products are used safely and effectively. These product label reviews are an essential part of the regulatory process before a pesticide can be registered and marketed.

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Understanding Document Comparison Software: A Key Tool for Regulatory Affairs in Crop Science

Much like in the pharmaceutical and medical device sectors, where the adoption of such software has proven to reduce workloads and the risk of errors that may cause recalls or stop-sales, the Crop Science industry is also beginning to recognize the value of integrating this technology.

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Rising regulatory demands: are medical device suppliers ready?

The global medical devices market is set to reach $886.80 billion in value by 2032 . As devices become more critical to patient outcomes, regulators’ quality and safety expectations and associated controls are increasing.

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FHIR: Transforming Product Labeling

The shift from paper-based to digital processes has opened enormous opportunities in the healthcare sector in terms of data sharing and content management. But data can only be shared efficiently and add value if systems can "talk" to each other. The term we use for how compatibly systems work together is "interoperability." Traditionally, the healthcare sector has suffered from a high lack of interoperability.

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Empowering Pharma and Regulatory Frameworks with Structured Content

Structured content ensures compliance in the pharmaceutical industry. Discover how FDA’s SPL and Canada’s SPM formats promote patient safety and efficiency.

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The Importance of Structured Content in Product Labeling

In the first of a three-part series on structured content and structured product labeling, we explore why structured content is important, its benefits, and best practices for implementation.

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The Critical Impact of Labeling Errors in the Pharmaceutical Industry

In the complex landscape of pharmaceutical manufacturing, every detail matters. From the formulation of the drug to its packaging and labeling, precision is vital. However, despite stringent regulations and quality control measures, labeling errors persist, posing significant risks to patient safety and public health.

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Regulatory Tools: Revolutionizing Promo Review

Regulatory authorities are approaching AI with understandable caution, recognizing its obvious opportunities as well as its inherent challenges. Workshops, workplans, input and industry collaboration are high on the agenda.

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How TVT helps the Top 5 Functions of Regulatory Professionals

The challenges faced by regulatory professionals are substantial. New products must be brought to market quickly and the pressure is on to turn projects around faster. Furthermore, regulations are constantly evolving, which means labeling and packaging must be updated.

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Off Label Marketing: How to Avoid False Claims in Pharma

The risk is high, whichever side of the coin you look at. Off-label marketing and other off-label promotion have led to some of the largest legal settlements in the pharmaceutical industry – up to $3 billion in one case

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Navigating Medical Device Regulations: How to Meet Labeling Artwork Compliance Standards

The medical devices regulations (MDRs) were introduced to take account of scientific and technological advances over the past two decades, but also due to problems interpreting previously existing regulations.

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The Ripple Effect: Exploring the Extensive Costs Associated with Product Recalls

It takes endurance and the tools of skilled professionals to advance a new product from R&D through to market. The investment is enormous, and the competition is breathing down the innovator's neck. Can you afford the costs of a recall or product delay?

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Sustainable Solutions: Enhancing Workflows through Paperless Document Reviews

Earth Day is a commitment to safeguarding and enhancing our natural environment, with an anticipated mobilization of over 1 billion people in 2024. At Schlafender Hase, when we thought about how Earth Day affected us as individuals and a company, we unanimously agreed: it's especially about trees and minimizing use of paper.

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Best Practices for your Promotional Review Process

The aim of a pharmaceutical promotional review process is to ensure the accuracy and compliance of promotional material with the relevant medical, legal, and regulatory aspects of a specific market.

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Ensuring Patient Safety: Medical Device Recall Process and Prevention Strategies

The costs of medical device recalls can run well into the millions of dollars. In terms of numbers of devices recalled, heading the unfortunate list of medical device recalls in recent times is a Class I recall of 38 million Vial2Bag fluid transfer systems by West Pharmaceuticals in 2019.

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Proofreading Regulated Documents in Pharma

Proofreading regulated documents in pharma presents unique challenges. Avoid the high risk of costly mistakes with best practices and by leveraging technology.

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A Guide to Proofreading Medical Writing

Medical writing describes a wide range of writing in the fields of medicine and healthcare. Discover more about medical writing and “a day in the life.”

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Proofreading Software: 6 Ways You Save

Comparison software offers immense savings, especially in regulated industries. Ask some of the leading pharmaceutical companies. Here are 6 Ways You Save.

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Best Practices for Labeling Readability

We will explore what we mean by readability and what key principles can guide us through regulations to make labeling readable and legible.

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Preparing for MoCRA – FDA’s Updated Cosmetics Framework

The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) is the most significant change to cosmetics regulation since 1938. Are you prepared?

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Comparison Software to Verify Drug Promotional Material

Ten years and $1 billion later, close your eyes and imagine; your product has been approved in the US by the Food and Drug Administration (FDA).

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8 Ways Barcodes Can Combat Counterfeit Medical Products

Counterfeit medical products, including drugs and devices, pose a serious global threat to public health.

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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.

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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 proofreading in life sciences can be a nightmare.

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The Importance of Braille Inspection on Packaging

Inspecting Braille on packaging is important for compliance in the pharmaceutical industry. Automated proofreading supports you with Braille inspection.

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Top Medical Device use Document Comparison Software

When the subject of proofreading comes up, most think of correcting written text in a document such as a book or a school essay. In the Medical Device industry, however, proofreading is a whole lot more than that.Packaging and labeling can include many elements such as instructions for use, company logo, symbols and numerous other graphics, as well as a variety of different barcodes. Everything has a purpose and must be correct before a device goes to market.

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5 Must-Do Activities in Montreal During RAPS Convergence 2023

Welcome, esteemed professionals attending RAPS Convergence in Montreal! To help you experience the best of what Montreal has to offer, we've compiled a list of five must-do activities during your visit. Get ready to explore the charm and excitement of this captivating Canadian metropolis!

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Top Pharma use Document Comparison Software

Top Pharma use document comparison software to proofread labeling. Why aren’t you? When the subject of proofreading comes up, most think of correcting written text in a document such as a book or a school essay. In the Pharma industry, however, proofreading is a whole lot more than that. Packaging and labeling include elements such ... Read more

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A Short History of Regulatory Authorities

Regulatory authorities are crucial for the safety and efficacy of medicines and medical devices. And yet, achieving the high level of regulation we have today has been a long road – with lives saved and lost along the way.

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A Guide to Medical Device Labeling Requirements

Navigating complex labeling requirements for medical devices. Your guide to the fundamentals of regulation and compliance and how automated proofreading can minimize your labeling risks.

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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?

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Artwork Approval Processes for Pharma & Med Device

Improving artwork design and artwork approval processes can save patient lives and enhance company viability.

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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.

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Why Spelling Errors Can Be Lethal in Medical Packaging

Spelling errors, missing information and language mistakes can lead to medical errors that put patient health at risk. Additionally, such errors can result in misprints, CAPA’s and product recalls.

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How to Reduce Drug Labeling Errors in Pharma

FDA (US), EMA (EU), ANSM (France), CFDA (China), BfArM (Germany) – just to name a few of the national and international bodies that regulate the pharmaceutical industry. They share a common purpose: to ensure the patient safety and efficacy of medicines. And for this, they have regulatory procedures.

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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.

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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.  

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Why is labeling important in the pharmaceutical industry?

Bringing a new drug to market demands a large investment on the part of a pharmaceutical company – often, $ 1 billion or more. Ensuring compliance with complex labeling regulations is part of that investment. In the following we look at why pharmaceutical labeling is so important and the different types of labeling.

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What is Document Comparison Software For Regulatory Affairs?

The major players in the Pharma and Medical Devices industries have either adopted or are in the process of adopting a software for document comparison. Like other technologies, this too has been a slow adoption despite it’s proven time, money, and stress savings. The goal of this article is to explain how document comparison software can help and why it is an essential part of any Regulatory Affairs tech stack.

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E-Labelling: Practical Next Steps for Medical Device Manufacturers

Practical next steps for medical device manufacturers & distributors as regulators demand the digital delivery of customer-facing product information in place of paper inserts.

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8 Ways RA can help get Products to Market Faster

Bringing a new drug to market is time-consuming and costly, and generally takes 10 years and costs over $1 billion. The smallest lapse in labeling and packaging can jeopardize even the most well-planned submission. A proofreading and comparison software can help you get there faster, safer.

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5 Ways You’re Wasting Time & Money in Regulatory Affairs

If you are proofreading manually, you are aware of how time-consuming it is.We have all heard the saying “time is money”, and this is very true for Regulatory Affairs professionals. In this article, we'll be exploring proofreading in Regulatory Affairs, and 5 ways that RA depts. are wasting money by relying on manual proofreading.

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13 Questions to Ask When Choosing Comparison Software

Settling on a text comparison solution that does not require you to change your existing processes can be a daunting task, but we are here to help! We’ve outlined 13 questions for you to ask before making your final choice.

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11 Ways Proofreading Is Easier with TVT 11

Using a proofreading software like TVT®, takes the stress out of proofreading by automating tasks.

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How to Attract and Retain Regulatory Affairs Professionals

As we move through 2022, Human Resource (HR) departments and recruiters are looking at the impact of the Great Resignation on regulatory affairs.The current trend to job switching, the “Great Resignation”, may be flattening out in some professions in mid-2022, but the difficulty of attracting and retaining top talent in regulatory affairs remains an ongoing challenge for pharmaceutical companies, and the stakes are high.

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10 Automated Proofreading Benefits that Make Your Life Easier

Whether you proofread labeling and packaging full-time, or proofreading is just one of your many tasks in your working day, automated proofreading with TVT, the Text Verification Tool©, will make your life easier.

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Barocde Compliance: 3 Rules for Barcodes in Life Sciences

Optimize barcode scanning precision in pharmaceutical, artwork, quality control, packaging, and printing industries with these indispensable tips. Avoid delays and errors for smooth workflow.

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Top Pharma Companies Automate Proofreading

Top pharma companies automate proofreading with TVT. Read all top 10 reasons.

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Are You Struggling to Proofread Foreign Languages or Braille?

“A different language is a different vision of life,” said the Italian film director, Federico Fellini.

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Manual vs Automated Proofreading

When was the last time you flew in a passenger jet? Would you have felt as safe if the jet didn’t have automated controls? These relieve pilots of repetitive actions, reducing the risk of error and allowing pilots to focus on broader tasks related to safety and operation.

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Why Data Integrity is Important in Pharma

Learn about Data Integrity and its crucial role in maintaining valuable data for various stakeholders, including patients, communities, and companies, through ALCOA and ALCOA+ principles.

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The True Cost of Manual Proofreading in Regulated Industries

Looking for more information on how you can improve your team’s proofreading practices? Learn how Lohmann & Rauscher reduced the number of correction cycles and gained significant time back by implementing TVT in their proofreading process.

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8 Secrets Proofreaders Don’t Want to Reveal

First, by proofreading, we mean text comparison of 2 files, like a manuscript versus a laid-out artwork of what should be the same text, not content correction of a single text. Over the years, many proofreaders have shared with us what manual text comparison really means for them. When they try to convince their boss to invest in electronic text comparison software, they usually present the business reasons, discussing ROI, risk avoidance, improved quality, time savings and so on.

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