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Linguistic Review - Regulatory Affairs - QbD Group (4)

Linguistic Review

The linguistic review process for Product Information (PI) can be complex, especially with the tight deadlines and high volume of documents imposed by regulatory authorities.

Whether you're preparing an English PI for a new application and maintaining it during the product lifecycle or ensuring accurate translations into 25 EU/EEA languages for products approved via the Centralised Procedure, every step requires precision.

At QbD Group, we can help you with these regulatory requirements —ensuring high-quality translations that comply with procedural timelines.

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What are the challenges?

One of the biggest challenges in the linguistic review process is the extremely short turnaround time for translations. Here’s what you’re up against:

  • Only 5 days for translations – After the CHMP issues its opinion on the Marketing Authorization Application (MAA) on day 210 (day 0 post-approval), you have just 5 calendar days to submit translations to the Member States (MS).
  • Final submission within 6 days – After the MS provide their comments on day 19 post-approval, the final approved translations —including tracked and clean word versions along with PDF versions— must be submitted within 6 days (on day 25 post-approval/day 235 of the MAA).

With 25 languages involved, this process can quickly turn into an administrative burden—final submissions often exceed 125 documents! Managing this efficiently requires both linguistic and regulatory expertise.

How can we help
Linguistic Review - Regulatory Affairs - QbD Group (3)

Why partner with QbD Group?

  • Efficient workflow: Our in-house Standard Operating Procedure (SOP) ensures consistency and quality.
  • Trusted translation network: We collaborate with qualified external vendors and have in-house linguistic experts.
  • Linguistic accuracy: Our team has a deep knowledge of QRD templates and stylistic matters.
  • Quality control tools: We have automated in-house tools that guarantee technical accuracy. 
  • End-to-end project management: From initial PI preparation to final approvals, we handle it all.

Additionally, we can assist with updating local compendia, reviewing and approving artwork, preparing local prescribing information, reviewing promotional and non-promotional materials, and more!

Let’s simplify your linguistic review process

10+ years of experience

250+ successful procedures

Accurate, compliant & timely translations

Full in-house review support

 

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Whether you need full in-house review support or prefer us to work alongside your internal teams, we tailor our approach to fit your needs.

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