Meet global regulatory expectations the first time with these efficient, cost-effective, and compliant product labeling solutions and considerations.
Speak with a Labeling Expert
Accurate and compliant labeling of an investigational medicinal product (IMP) is an important and integral part of clinical trial operations. A misstep in labeling can lead to significant delays, affecting the entire study’s timeline and potentially incurring costs ranging from $100,000 to $700,000 in hard expenses. In worst-case scenarios, incorrect labeling might necessitate a complete product reproduction. Learn more about the strategies and solutions leading sponsors are leveraging to ensure excellence and efficiency in IMP labeling for clinical trials.
Patients and healthcare professionals around the world depend on product labels that have been effectively localized for safety and effective treatment. Accurate and culturally relevant labeling ensures comprehension of usage, dosage, and safety information, which in turn facilitates wider product acceptance and adherence to local regulatory standards. Here are some key solutions to successfully navigate global labeling
requirements.
Sponsors can follow these steps for an efficient, cost-effective, and compliant labeling solution that is suitable for global markets and diverse patient populations:
Assign Study-Level Owners
Labeling fails without clear responsibilities and signoff authority.
Map Market-Specific Requirements
Every country has different rules—know them upfront.
Build a Locked Master Label
Use structured content to prevent drift and enable reuse.
Translate Once, Reuse Often
Apply translation memory to cut time and cost.
Labeling is more than a checkbox—it’s critical to trial approval, patient safety, and global compliance. From multilingual content to country-specific regulations and eLabeling trends, our experts help you get it right the first time.
While printed IMP labels remain mandatory, supplementing them with eLabels unlocks real-time updates and mobile-friendly access. Patients and staff can instantly view multilingual content, helping reduce confusion and cutting waste through digital updates.
From eLabeling solution to localization strategy, we’ll help you meet regulatory demands and stay on timeline.
