AI is revolutionizing drug regulation at every stage—from speeding reviews to improving safety monitoring and replacing animal testing. Here’s a clear and engaging breakdown, complete with real-world examples: 1. Faster, Smarter Drug Reviews Elsa: FDA’s Generative AI Assistant In early […]
Artificial Intelligence (AI) is revolutionizing life science sectors such as clinical trials and regulatory compliance. AI speeds up drug development through improved trial design, automation of compliance processes, data management, and streamlining. 1. AI‑Driven Clinical Trial Design and Execution The
Artificial Intelligence is transforming the pharmaceutical industry by solving old problems in drug development and clinical trial rules. This article shows how AI is changing the field. Introduction: Challenges in Pharma and the Rise of AI Developing a new drug
Introduction: Innovation in Drug Development Pharmaceutical companies face significant challenges when bringing new products to market. The drug development process is a lengthy and expensive one, taking between 10 to 15 years. Clinical trials are also prone to failure at
Introduction to Accurate Translation of Life Science Life science translation encompasses pharmaceutical, medical, and clinical research content. Life science translation is different from general translation. It requires precise terminologies, compliance with regulatory requirements, and industry knowledge. Translation errors can lead
FDA Layoff Crisis: Potential Impact on Drug Approvals The recent large-scale layoffs at the U.S. Food and Drug Administration (FDA) may have wide-ranging implications for pharmaceutical companies’ drug registration and approval processes. The FDA has about 18,000 employees. Their decision
Regulatory compliance in the life sciences field is a complex landscape, particularly when it intersects with multilingual requirements. From pharmaceutical labeling to clinical trial documentation, ensuring compliance hinges on accurate and culturally adapted translations. Below are practical tips for successfully
As artificial intelligence (AI) translation technology rapidly advances, life science translation is becoming a key driver of transformation in the pharmaceutical industry. AI-powered translation is already making a significant impact in the pharmaceutical industry. Below are some practical cases demonstrating
Selling pharmaceuticals and medical devices in the EU market requires compliance with strict regulations and ensuring that all regulatory documents meet the necessary standards. Given the EU’s 24 official languages and complex regulatory framework, ensuring accuracy and compliance in documentation
The NewCo model is becoming increasingly popular among Chinese biotech companies looking to expand internationally. In this model, a Chinese biotech company gives overseas rights for its new drug to a newly created NewCo. The NewCo gets money from U.S.
As global clinical trials continue to expand, accurate clinical translation of documents has become an indispensable component of the journey from lab to market. Despite the administrative burdens and tight regulatory timelines faced by clinical teams, accuracy in clinical translation
High-quality translation is essential when launching pharmaceutical products in a new market, providing treatment in a patient’s native language, or exporting medical devices. According to the World Health Organization (WHO), multilingual communication bridges gaps and promotes understanding between people. It
