Lisa, it might help to get a notarized statement from a credentialed translator that this is indeed the case -- that the forms are identical except for (___fill in the blank____), and that all (___fill in the blank___) have been translated.
If you go to the website of the American Translators Association, you should be able to find several medpharma translators who are credentialed by the ATA and who work in your language pair. Or you could ask a translation company to provide that certificate. It shouldn't be nearly as expensive as translation, because the translator only needs to compare the pages and certify that they are indeed identical.
Best,
Lee
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Lee Seaman
President
Seaman Medical, Inc.
Bellingham WA
United States
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Original Message:
Sent: 01-29-2015 14:40
From: Lisa Burns
Subject: Batch Record Translation
Hi all -
Does anyone have any experience submitting a translated Master Batch Record and one translated Executed Batch Record to CDER while the remaining Batch Records are in the original language? Assuming the only differences are the numerals in the fillable fields and any deviations or hand-written comments are translated, does this seem reasonable?
Thanks in advance.
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Lisa Burns
B. Braun Medical Inc.
Allentown PA
United States
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