Posts by Geoff LeCain

The world of pharmaceutical labeling is full of terms and acronyms. Here are 39 terms to help you get through 2023 and beyond.

Pharmaceutical product labeling deviations can be hard to manage manually. Let’s look at how integrated software solutions can help.

SPL and SPM each play a vital role in making drug information easy for health providers and patients to understand.

When you revise a pharmaceutical label, you need a plan for tracking the change. Here’s why it’s important and how to make it manageable.

The time has come for all pharmaceutical companies to submit all REMS documents electronically. Here’s what you need to know.

In this blog, we look at the 12 good pharmacovigilance practices (GVPs) you should follow in 2023 and beyond.

To market a pharmaceutical drug in the European Union, you must provide a pharmacovigilance system master file (PSMF). In this blog, we explain what that is, why you need it, and what’s included.

In 2023, regulatory tracking software will no longer be a luxury – it will be a necessity. Here’s how it can set you up for success.

Pharmaceutical drug labels are required for every drug. But why are they important? In this guide, we explore the role pharma labeling plays and why it’s so essential.

The FDA proposes a rule that would revise the National Drug Code format. What does this mean, and how may it impact you? Read on to find out.

Creating SPL and SPM files that are compliant and error-free is key to successful submissions. Regulatory submission software can help.