QbD Group streamlines linguistic reviews for a leading pharma client, ensuring compliance and accuracy across 25 EU/EEA languages while meeting stringent regulatory deadlines.
As one of the world’s leading pharmaceutical companies, our client develops and distributes innovative medicinal products that improve patient care. Operating across diverse markets, they must ensure that Product Information (PI) remains clear, precise, and compliant in multiple languages while meeting stringent regulatory requirements. With ever-evolving guidelines and tight submission deadlines, maintaining compliance across 25 EU/EEA languages is a major operational challenge.
Since 2010, QbD Group has partnered with this pharmaceutical leader to manage the intricate post-approval linguistic review process for a family of medicinal products. The complexity of coordinating multiple translations, ensuring alignment with QRD guidelines, and adhering to EMA procedures created significant challenges, including:
To ensure efficiency and accuracy, QbD Group developed a structured, standardized approach to translation management, quality control, and submission coordination. Our key strategies include:
With deep expertise in EMA procedures, QbD Group has successfully managed over 250 linguistic review procedures, ensuring:
By combining regulatory know-how with an efficient, structured approach, QbD Group continues to support our client in maintaining compliance and ensuring clear, accurate product information across multiple markets.
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