Working languages:
English to German

GunnarBox
Regulatory compliance in translation

Germany
Local time: 02:44 CET (GMT+1)

Native in: German Native in German
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Account type Freelance translator and/or interpreter
Data security Created by Evelio Clavel-Rosales This person has a SecurePRO™ card. Because this person is not a ProZ.com Plus subscriber, to view his or her SecurePRO™ card you must be a ProZ.com Business member or Plus subscriber.
Affiliations
Blue Board affiliation:
Services Translation, Editing/proofreading, Project management
Expertise
Specializes in:
Biology (-tech,-chem,micro-)Medical: Pharmaceuticals
Rates

Translation education PhD - Albert Einstein University of Ulm
Experience Years of experience: 17. Registered at ProZ.com: Sep 2014.
ProZ.com Certified PRO certificate(s) N/A
Credentials N/A
Memberships N/A
Software Adobe Acrobat, memoQ, Microsoft Office Pro, Microsoft Word, Powerpoint
CV/Resume CV available upon request
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.

Yours sincerely,

Gunnar Box (PhD)
Keywords: SmPC, PIL, Label, excipients, MRP, DCP, CP, excipients, MedDRA, EDQM. See more.SmPC, PIL, Label, excipients, MRP, DCP, CP, excipients, MedDRA, EDQM, English, German, biology, review. See less.


Profile last updated
May 13, 2016



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