---
title: "Linguistic Review — Regulatory Affairs | QbD Group"
description: "One of the biggest challenges in the linguistic review process is the extremely short turnaround time for translations. QbD Group ensures high-quality tran"
url: https://qbdgroup.com/en/services/regulatory-affairs/linguistic-review
type: "Page"
language: en
publisher: "QbD Group"
citation: "QbD Group, \"Linguistic Review — Regulatory Affairs | QbD Group\", https://qbdgroup.com/en/services/regulatory-affairs/linguistic-review"
---

# Linguistic Review

Precise, compliant translations under tight deadlines

One of the biggest challenges in the linguistic review process is the extremely short turnaround time for translations. QbD Group ensures high-quality translations that comply with procedural timelines.

## What are the challenges?

One of the biggest challenges in the linguistic review process is the **extremely short turnaround time** for translations. After the CHMP issues its opinion on the Marketing Authorization Application (MAA), you have just **5 calendar days** to submit translations to the Member States.

For maintenance (variations, renewals, post-authorization measures), translations must be submitted within **14 calendar days** after the CHMP Opinion or Commission Decision.

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, every step requires precision.

## How we support you

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

### Multi-language translations

Accurate translations across all 25 EU/EEA languages with regulatory precision.

### Tight deadline management

Proven ability to deliver within the strict 5-day and 14-day regulatory timelines.

### Product information management

Complete PI lifecycle management from initial creation through maintenance.

### Quality assurance

Rigorous quality checks ensuring consistency and regulatory compliance.

Why QbD Group

## Your trusted partner

Our linguistic review team combines regulatory expertise with language precision.

Proven track record in meeting tight regulatory translation deadlines.

Coverage across all 25 EU/EEA languages.

Deep understanding of pharmaceutical terminology and regulatory requirements.

Seamless integration with your regulatory submission process.

## Let's talk Regulatory Affairs

From regulatory strategy to product approval, our experts are ready to guide you through every step.

Contact us

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Source: https://qbdgroup.com/en/services/regulatory-affairs/linguistic-review — © QbD Group. Quote freely with attribution and a link back.