In the chemical industry, timing is key. The Summary of Product Characteristics (SPC) is central to the EU authorisation process, so any delay in producing compliant translations can jeopardise product launches.
One of our clients took a proactive approach: rather than waiting for the updated English draft from ECHA, they asked us to translate the draft SPC into 25 languages ahead of the BPC meeting. This foresight gave them a crucial head start, making it easy to adapt once ECHA issued its feedback and final deadlines.
Key challenges
- Managing 25 languages simultaneously
- Meeting the tight 5–10 day deadlines set by ECHA
- Navigating ECHA’s unique process, where a draft is followed by an updated version
Our approach
- Early translation of the draft SPC into 25 languages
- Flexible updates after ECHA feedback
- In-country expert translators with a strong chemical background
- Centralised glossary for full terminology consistency
- Streamlined project management and rigorous quality checks
The results
- 25 translations delivered on time despite evolving source texts
- More breathing room for the client once ECHA released updates
- Zero unnecessary work thanks to targeted updates only
Takeaway
This case demonstrates that proactive SPC translation allows companies to:
- anticipate regulatory challenges instead of reacting to them
- manage evolving SPC files efficiently, whether the changes are minor or extensive
Conclusion: By combining foresight with our specialised SPC translation workflow, our client transformed a regulatory challenge into a success story – achieving compliance, efficiency and peace of mind.