FDA Inspection Support
FDA Inspection Support
Our consultants with FDA inspection experience meet the needs of clients at every stage.
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01Before an FDA Inspection Pre-inspection support
General training on FDA inspections (what an inspection involves, how much to translate into English in advance, etc.)
Support for English translation of documents
Data integrity training for FDA inspection readiness
Gap analysis between current GMP practice and the requirements of cGMP and other guidelines
cGMP gap analysis by former FDA investigators who partner with us
Support for revising and creating GMP SOPs to close the gaps, and related training
Proposals for reviewing facilities and equipment to close the gaps, and support for establishing the necessary qualification and validation
Q&A training in preparation for FDA inspections
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02During an FDA Inspection On-site inspection support
Accompanying FDA investigators on plant tours
Back-room support during document reviews
Explanation of findings raised during the inspection
Proposals for corrective measures for findings raised during the inspection
Introductions to interpreters for FDA inspections
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03Form 483 Response Form 483 response support
Explanation of Form 483 observations
Support for drafting, reviewing and translating into English responses to the observations
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04Gap AnalysisGap analysis
First, where needed, we analyze the gaps between the requirements of laws, regulations and guidelines and your current situation (gap analysis) to understand where you stand. After the gap analysis, we propose solutions that fit your objectives.
Track Record
PERFORMANCE
Explore the projects we have supported so far.
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For questions or consultations about our services, please call us or use the contact form.
Hours: weekdays 9:00–18:00 (JST)
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CONTACT