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
Medical device companies are racing to reach international markets. The numbers tell the story: global medical device sales hit USD 640.45 billion in 2024 and are projected to grow from USD 678.88 billion in 2025 to approximately USD 1,146.95 billion
The biotech sector is on the cusp of a surge in novel therapies. Recent FDA approvals were driven by first-in-class drugs and expedited review paths. Nearly half of 50 new biologic and molecular therapies approved by 2024 will be first-in-class
Medical records translation doesn’t get nearly as much attention in global healthcare as it requires. Whether you’re running a hospital, managing a clinical trial across borders, or helping patients seek treatment abroad, the way you handle medical records in different
Over the past decade, China’s biotech sector has surged onto the world stage in drug licensing. From just 55 China‐related deals in 2015, Chinese biopharma companies were involved in 213 deals by 2024. Total deal value jumped from $3.1 billion
