Vineed Ravindranath

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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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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Avalis Publishing Case Study – Compliance through Watertight Version Control

Compliance, document integrity and a watertight version control process underpin all its publishing activities. Version control is a key factor as the two business partners deal with a large number of document updates and changes. Many of its clients do not have direct expertise in publishing the required regulatory documents.

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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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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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July 11, 2025

Schlafender Hase Team

The Impact of e-Labeling on Your Daily Work in Regulatory Affairs

The shift toward electronic labeling (e-labeling) and electronic Product Information (ePI) is no longer a distant future, it's happening now. For Regulatory Affairs teams, this transformation brings both questions and opportunities. If you’re wondering what this shift means for your daily work, you're not alone.

3 minutes read

The Impact of e-Labeling on Your Daily Work in Regulatory Affairs

July 4, 2025

Schlafender Hase Team

Why Automated Proofreading Matters in Biotech Scale-Ups

In a fast-scaling biotech environment, you’re managing regulatory documents, clinical content, labeling, instructions for use, artwork, and important safety information. These aren’t just words on a page, they're the backbone of your product’s journey to patients, regulators, and partners. And every version must be accurate, consistent, and audit ready.

2 minutes read

Why Automated Proofreading Matters in Biotech Scale-Ups

June 30, 2025

Schlafender Hase Team

Schlafender Hase Announces Change in Executive Leadership

Founder & Chief Executive Officer Frank Hessler to join advisory board; André Cerbe to continue as sole Chief Executive Officer, supported by a strong Leadership team including Chief Technology Officer Karthikeyan Pandiyan.

2 minutes read