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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August 19, 2025

Schlafender Hase Team

FHIR-Based ePI: A Practical Playbook for Regulatory and Labeling Teams

E-labeling is no longer on the horizon - it’s here. That’s why we created this playbook: a one-stop resource combining expert insights, survey data, and practical guidance for life sciences professionals.

< 1 minute read

FHIR-Based ePI: A Practical Playbook for Regulatory and Labeling Teams

August 18, 2025

Schlafender Hase Team

From Review Bottlenecks to Business Gains: How TVT Transforms Content Verification Across Regulated Industries

In regulated industries, content verification has become a business-critical function. Regulatory scrutiny is increasing. Product portfolios are growing. Content is more complex and multilingual than ever before.

3 minutes read

From Review Bottlenecks to Business Gains: How TVT Transforms Content Verification Across Regulated Industries

August 18, 2025

Schlafender Hase Team

Every Detail Matters: Proofreading in Highly Regulated Industries

In regulated industries like pharma, medical device, fast-moving consumer goods (FMCG), and crop science, documentation isn’t just part of the process — it is the process. It’s what stands between your product and the market, your team and regulatory approval, your brand and consumer trust.

2 minutes read