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A Decade of Excellence: Linguistic Review Support for a Global Pharma Leader​

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Regulatory Affairs
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Pharma & Biotech

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.

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Challenge
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Results
Results
Challenge

Challenge

Regulatory & linguistic complexity

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:

  • Managing PI updates across 25 EU/EEA languages while meeting strict submission deadlines.
  • Ensuring accuracy and consistency in translations across multiple regulatory frameworks.
  • Implementing an efficient workflow to standardize processes and reduce errors.
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Approach

Approach

Streamlining the linguistic review process

To ensure efficiency and accuracy, QbD Group developed a structured, standardized approach to translation management, quality control, and submission coordination. Our key strategies include:

  • Early preparation of the English PI to align with QRD guidelines before MAA or post-approval submissions.
  • Clear, well-defined processes supported by specialized software tools to ensure precision and consistency.
  • A proactive workflow to meet strict regulatory deadlines without compromising quality.
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Results

Results

Delivering regulatory excellence

With deep expertise in EMA procedures, QbD Group has successfully managed over 250 linguistic review procedures, ensuring:

  • High-quality submissions that meet stringent regulatory requirements.
  • Standardized processes and automation for enhanced accuracy and efficiency.
  • A long-standing partnership built on trust, expertise, and proven results.

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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Let’s discuss how QbD Group can help streamline compliance and ensure accuracy. Fill out the form and we’ll be in touch soon!

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