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Posts by Geoff LeCain

Pharmaceutical Labeling Terms
39 Pharmaceutical Labeling Terms You Need to Know [Updated for 2023]

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
Using Integrated Software Solutions to Manage Pharmaceutical Product Labeling Deviations

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

Canada and Amercan flag
3 Key Differences Between SPL & SPM

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

Pharmaceutical Label Changes
5 Tips for Tracking Pharmaceutical Label Changes

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.

REMS Document
Submitting Electronic REMS Documents: What You Need to Know [2023]

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

Good Pharmacovigilance Practices
12 Good Pharmacovigilance Practices (GVPs) for 2023

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

Pharmacovigilance System Master File
Understanding the 6 Important Parts of a Pharmacovigilance System Master File (PSMF)

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.

Why You Need Regulatory Tracking Software
7 Reasons Why You Need Regulatory Tracking Software in 2023

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.

Pharma Labeling Basics
Pharma Labeling Basics: Why It’s Essential & Who It Affects [GUIDE]

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.

Pharmacist
Your Guide to the Proposed National Drug Code Format Changes [2022]

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.

Choose Regulatory Submission Software
5 Expert Tips for Choosing Regulatory Submission Software

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