{"id":333,"date":"2024-06-15T01:31:36","date_gmt":"2024-06-15T01:31:36","guid":{"rendered":"https:\/\/pharmconsul-hata.com\/?page_id=333"},"modified":"2026-01-27T02:10:38","modified_gmt":"2026-01-27T02:10:38","slug":"%e3%82%ac%e3%82%a4%e3%83%89%e3%83%a9%e3%82%a4%e3%83%b3%e3%81%b8%e3%81%ae%e5%af%be%e5%bf%9c%e8%a7%a3%e8%aa%ac","status":"publish","type":"page","link":"https:\/\/pharmconsul-hata.com\/","title":{"rendered":"Top page"},"content":{"rendered":"\n

Support for: Pharmaceutical guidances and rules implementation, documents generation (Data Integrity and Quality culture implementation, CTD submission), training, mock-audit and interpreter for audit.<\/p>\n\n\n\n

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Guidance Training<\/h2>\n\n\n\n

Rules for Marketing approval and GMP differs in each country. Every country has its rules added to the harmonized guidance, so that environment and situation are explained.
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Documented Procedures<\/h6>\n\n\n\n

Internal documents and SOPs will be generated to adopt internationally harmonized guidance considering the suitable level of implementation for your organization.
(Photo: Communication time at Czech conference)<\/p>\n\n\n\n

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Documents Generation<\/h6>\n\n\n\n

Acceptable documents and papers will be generated (CTD etc.)
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Mock-audit, Interpretation<\/h6>\n\n\n\n

Supprt and help for inspection available
\uff08Photo: Presentaion at US conference\uff09<\/p>\n<\/div>\n\n\n\n

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Services<\/strong><\/p>\n<\/div>\n\n\n\n

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\u30fbGuidance Training<\/h4>\n\n\n\n

\u3000\u3000\u30fbFeatures of Japan, US and EU quality guidances
\u3000\u3000\u30fbUpdated GMPs (including requirements for each contry)
\u3000\u3000\u30fbStability Testing in development and in production<\/p>\n<\/div>\n\n\n\n

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8,000 yen\/hr (excluding tax, transportation)<\/h6>\n<\/div>\n<\/div>\n\n\n\n
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\u30fbBrush up SOPs<\/h4>\n\n\n\n

\u3000\u3000\u30fbUpdate for quality SOPs (QM, QA, QC)<\/p>\n<\/div>\n\n\n\n

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4,000 yen\/hr<\/h6>\n<\/div>\n<\/div>\n\n\n\n
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\u30fbDocuments Optimization<\/h4>\n\n\n\n

\u3000\u3000\u30fbDocuments for submission (CTD, reports for customers)<\/p>\n<\/div>\n\n\n\n

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4,000 yen\/hr<\/h6>\n<\/div>\n<\/div>\n\n\n\n
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\u30fbMock-audit<\/h4>\n\n\n\n

\u3000\u3000\u30fbAPI
\u3000\u3000\u30fbDosage form, Drug product<\/p>\n<\/div>\n\n\n\n

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4,000 yen\/hr<\/h6>\n\n\n\n

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\u30fbInterpretation<\/h4>\n\n\n\n

\u3000\u3000\u30fbFDA or customer audit interpretation, English to Japanese <\/p>\n<\/div>\n\n\n\n

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4,000 yen\/hr<\/h6>\n<\/div>\n<\/div>\n\n\n\n

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Carrier<\/h6>\n<\/div>\n\n\n\n
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Naotaka Hata, PhD has an experience of:

\u30fbPharmaceutical quality guidance survey: 26 yrs
\u30fbQuality assurance for Drug products and Investigational new drugs: 9 yrs
\u30fbAnalytical testing: 13 yrs
\u30fbProduct planning and coordination: 7 yrs
\u30fbPharmaceutical industry associations member: 11yrs<\/h6>\n<\/div>\n\n\n\n
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Availability<\/h6>\n<\/div>\n\n\n\n
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Monday : 9:00-17:00
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Contact me<\/h6>\n\n\n\n
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Please send e-mail to:<\/h6>\n\n\n\n
q12.hataconsul@gmail.com
Naotaka Hata
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