There’s a growing need for medical software as healthcare progresses to be more accessible to patients in emergencies and regardless of location. Telehealth apps, diagnostic tools, and electronic health records are some of the common ones that already help patients […]
When Pfizer faced a $2.3 billion fine in 2009 for off-label marketing violations, it taught the entire pharmaceutical industry something that’s stuck since then. That lesson is that marketing medicine isn’t the same as selling consumer goods. There’s everything from
Regulations can make or break a product’s future in Europe. The EU In Vitro Diagnostics Regulation (IVDR) makes compliance just as important as innovation. No matter how advanced a diagnostic test may be, it cannot reach patients unless it meets
In the pharmaceutical industry, accurate translation is a no-brainer. Every document, from clinical trial protocols to regulatory submissions, patient information leaflets, labelling, and safety materials, must be written in clear and appropriate language. Any mistake in translation can lead to
Pharmaceutical labels are more than packaging. They contain dosage instructions, safety warnings, storage conditions, and ingredient details that protect patients and guide healthcare providers. In international markets, accurate label translation is essential, as even a single mistake can cause compliance
Entering or expanding into a new market is a major opportunity for pharmaceutical companies, but it also exposes them to strict and varying rules across regions. Without preparation, even the most promising product can face delays, rejected applications, or costly
China’s pharmaceutical market is growing quickly and is now one of the largest in the world. Because of this, drug registration with the China NMPA (National Medical Products Administration) is more important than ever for companies planning to enter or
In 2018, a pharmaceutical company’s clinical trial in Latin America faced a devastating setback. A critical dosage instruction was mistranslated in patient questionnaires. This led to misreported adverse events and a six-month regulatory delay. The root cause? A simple translation
Medical device makers entering Europe face one key challenge: creating a compliant clinical evaluation report (CER). This document proves device safety and performance under the EU Medical Device Regulation (MDR). A well-prepared CER not only helps with regulatory approval but
A single mistranslated word can mean the difference between life and death. Which means medical terminology translation becomes far more than merely converting text from one language to another. Take, for example, when Willie Ramirez fell into a coma in
The first half of 2025 has confirmed a seismic shift in the pharmaceutical landscape: GLP-1 receptor agonists — a class of new drug therapies for diabetes and obesity — now dominate global sales charts. Among all medicines worldwide, treatments for
The electronic Common Technical Document (eCTD) has changed how pharmaceutical and life sciences companies submit regulatory applications worldwide. This standardized format simplifies the submission process for drug and medical device registration. Major regulatory agencies like the FDA, EMA, NMPA, and
