{"id":5813,"date":"2023-04-18T11:03:05","date_gmt":"2023-04-18T09:03:05","guid":{"rendered":"http:\/\/164.90.225.225\/home\/"},"modified":"2026-02-23T16:35:19","modified_gmt":"2026-02-23T15:35:19","slug":"home","status":"publish","type":"page","link":"https:\/\/www.quinta.cz\/cs\/","title":{"rendered":"Home"},"content":{"rendered":"

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QUINTA-ANALYTICA<\/h1><\/span>
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Farmaceutick\u00e1 CRO s certifikac\u00ed GxP pro analytick\u00fd v\u00fdvoj a QC, klinick\u00e9 studie a bioanalytiku<\/h2><\/span>
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\"Quinta<\/a><\/span><\/div><\/div><\/div>
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Full-service CRO pro mal\u00e9 molekuly, biologika a biosimilars, v\u010detn\u011b hum\u00e1nn\u00edch i veterin\u00e1rn\u00edch IMP<\/p>\n<\/div><\/div><\/div>

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Od BE\/BA\/PK studi\u00ed p\u0159es GLP\/GCP bioanalytiku a GMP QC a\u017e po analytick\u00fd R&D a CMC podporu<\/p>\n<\/div><\/div><\/div>

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Z\u00e1zem\u00ed ve st\u0159edn\u00ed Evrop\u011b (Praha\/Brno\/Ostrava) s glob\u00e1ln\u00ed dod\u00e1vkou slu\u017eeb v re\u017eimu GxP<\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div>\n

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FARMACEUTICK\u00c9 ANAL\u00ddZY<\/h3><\/span>
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Validace analytick\u00fdch metod, kontrola kvality, stabilitn\u00ed studie (v\u010detn\u011b HAPI), GMP batch release a dal\u0161\u00ed slu\u017eby.<\/p>\n<\/div>

V\u00edce informac\u00ed<\/span><\/a><\/div><\/div><\/div><\/div><\/div>
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KLINICK\u00c9 TESTOV\u00c1N\u00cd<\/h3><\/span>
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BE\/BA\/PK studie in-house ve dvou klinick\u00fdch jednotk\u00e1ch, s v\u00edce ne\u017e 300 dokon\u010den\u00fdmi studiemi.<\/p>\n<\/div>

V\u00edce informac\u00ed<\/span><\/a><\/div><\/div><\/div><\/div><\/div>
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BIOANALYTICK\u00c9 TESTOV\u00c1N\u00cd<\/h3><\/span>
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GLP\/GCP bioanalytika pro preklinick\u00e9 i klinick\u00e9 studie a\u017e do f\u00e1ze III, v\u010detn\u011b statistick\u00e9ho vyhodnocen\u00ed.<\/p>\n<\/div>

V\u00edce informac\u00ed<\/span><\/a><\/div><\/div><\/div><\/div><\/div>
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ANALYTICK\u00dd V\u00ddZKUM A V\u00ddVOJ<\/h3><\/span>
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V\u00fdvoj a validace metod, v\u00fdzkum ne\u010distot, degrada\u010dn\u00ed studie, stopov\u00e9 anal\u00fdzy, anal\u00fdza nitrosamin\u016f a dal\u0161\u00ed.<\/p>\n<\/div>

V\u00edce informac\u00ed<\/span><\/a><\/div><\/div><\/div><\/div><\/div>
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BIOFARMACEUTICK\u00c9 ANAL\u00ddZY<\/h3><\/span>
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Charakterizace, GxP validace bioanalytick\u00fdch metod, transfer metod, bun\u011b\u010dn\u00e9 eseje pro biologika a biosimilars.<\/p>\n<\/div>

V\u00edce informac\u00ed<\/span><\/a><\/div><\/div><\/div><\/div><\/div>
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Additional Services<\/h2><\/span>
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NITROSAMINES ANALYSIS<\/h4><\/span>
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Based on isotopically labeled standards, our customizable in-house detection methods are available immediately.<\/p>\n<\/div>

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More Info <\/i><\/a><\/h1><\/span>
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MONITORING STUDI\u00cd<\/h4><\/span>
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Oversight of participant health and correctness of treatments during clinical studies.<\/p>\n<\/div><\/div><\/div>

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FARMAKOVIGILANCE<\/h4><\/span>
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Monitoring of daily routine to detect unrecognized adverse events, plus assess and ensure drug safety.<\/p>\n<\/div><\/div><\/div>

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AUDIT MODULU 3<\/h4><\/span>
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Thorough dossier M3 data audit to ensure consistency and compliance with regulatory requirements.<\/p>\n<\/div><\/div><\/div>

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KOMPILACE IMPD<\/h4><\/span>
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As an EU based company we are well-placed to help create & develop your IMPD.<\/p>\n<\/div><\/div><\/div>

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Ot\u00e1zky na obchodn\u00ed t\u00fdm?<\/p><\/span>

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Our Sales team is ready to help: sales@quinta.cz<\/a><\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div>\n

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Pln\u011b certifikov\u00e1no<\/h2><\/span>
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As holders of GMP, GLP and GCP certifications for human medicinal products, and GMP certification for veterinary medicinal products, Quinta is regularly, and successfully, audited by the State Institute for Drug Control (S\u00daKL) and US FDA.<\/p>\n

All of our licenses and certifications are available for download below.<\/p>\n<\/div>

GMP Certificates of Compliance<\/h4>\n

Manufacturer \u2013 HIMP (Quality Control) \u2013 Prague Site<\/a>
\nManufacturer \u2013 HMP (Quality Control) \u2013 Prague Site<\/a>
\nControl Laboratory (Veterinary) \u2013 Prague site<\/a><\/p>\n

Manufacturer \u2013 HIMP (Quality Control) \u2013 Brno Site<\/a>
\nManufacturer \u2013 HMP (Quality Control) \u2013 Brno Site<\/a>
\nControl Laboratory (Veterinary) \u2013 Brno site<\/a><\/p>\n

GLP Certificate<\/strong><\/h4>\n

Certificate of Good Laboratory Practice<\/a><\/p>\n

GCP Certificate<\/h4>\n

Certificate of Good Clinical Practice \u2013 Prague site<\/a>
\nCertificate of Good Clinical Practice \u2013 Ostrava clinic<\/a><\/p>\n

FDA Inspections<\/h4>\n

Our company is proud to have successfully undergone more than 12 inspections by the FDA over the last years. Our dedicated Quality Assurance team can produce relevant documentation upon request. For additional information visit the U.S. FDA data dashboard<\/a>.<\/p>\n<\/div>

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If you\u2019re unable to download these certificates, please contact us\u00a0quinta@quinta.cz<\/a>\u00a0and we\u2019ll be happy to email them to you.<\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div>

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More about Quinta<\/h4><\/span>
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Kompletn\u00ed \u0159e\u0161en\u00ed<\/h4><\/span>
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Novinky<\/h4><\/span>
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M\u00e1te dotazy?<\/h2><\/span>
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Kontaktujte n\u00e1s p\u0159\u00edmo nebo pomoc\u00ed n\u00ed\u017ee uveden\u00e9ho formul\u00e1\u0159e.<\/p>\n<\/div>

quinta@quinta.cz<\/p>\n<\/div><\/div><\/div>

+420 242 454 311<\/p>\n<\/div><\/div><\/div><\/div>\n

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