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.