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Bio
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.