Dear client,
I have been working in the translation business since 2006 with a strong focus on pharmaceutical and scientific texts. I hold a Phd in Microbiology.

Areas of expertise: Biology (microbiology), chemistry, oncology, medicine, toxicology and pharmacology.

My current work focus lies on pharmaceutical labelling, time critical projects and consulting with a key focus on QRD compliance and the translation processes during MRP/DCP and CP.

I am a trained QRD reviewer and offer QRD review services for translators, agencies and regulatory affairs departments.

My services include:

- Review for SmPC, Label and PL translations

- Patient friendliness revision of German PIL texts as a medical writer

- Review of translations for scientific texts with a focus on microbiology and oncology

- QRD template reviews (MRP/DCP or CP templates) in German and all other EU languages

- QRD formatting reviews and updates


Regulatory compliance Review

For QRD dependent documents my service s include a full regulatory compliance check. The check focusses on relevant guidelines and official sources like:

- Table of non-standard abbreviations
- List of EEA country names
- MedDRA
- EDQM database
- ICD 9 and 10 terms
- Decisions on QRD stylistic matters
- Excipients guideline
- Readability guideline and lay term databases for PILs
- QRD approved terminology and black listed terms


I can also consult companies in organising translations of SmPC/PL and Label documents (Annex I to III) during MRP/DCP and CP projects and am a trained regulatory support specialist.
Please feel free to contact me.

I am looking forward to support you with your projects.

Yours sincerely,

Gunnar Box (PhD)