QUINTA-ANALYTICA
Farmaceutická CRO s certifikací GxP pro analytický vývoj a QC, klinické studie a bioanalytiku
Full-service CRO pro malé molekuly, biologika a biosimilars, včetně humánních i veterinárních IMP
Od BE/BA/PK studií přes GLP/GCP bioanalytiku a GMP QC až po analytický R&D a CMC podporu
Zázemí ve střední Evropě (Praha/Brno/Ostrava) s globální dodávkou služeb v režimu GxP
Additional Services
NITROSAMINES ANALYSIS
Based on isotopically labeled standards, our customizable in-house detection methods are available immediately.
MONITORING STUDIÍ
Oversight of participant health and correctness of treatments during clinical studies.
FARMAKOVIGILANCE
Monitoring of daily routine to detect unrecognized adverse events, plus assess and ensure drug safety.
AUDIT MODULU 3
Thorough dossier M3 data audit to ensure consistency and compliance with regulatory requirements.
KOMPILACE IMPD
As an EU based company we are well-placed to help create & develop your IMPD.
Otázky na obchodní tým?
Our Sales team is ready to help: sales@quinta.cz
Plně certifikováno
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 (SÚKL) and US FDA.
All of our licenses and certifications are available for download below.
GMP Certificates of Compliance
Manufacturer – HIMP (Quality Control) – Prague Site
Manufacturer – HMP (Quality Control) – Prague Site
Control Laboratory (Veterinary) – Prague site
Manufacturer – HIMP (Quality Control) – Brno Site
Manufacturer – HMP (Quality Control) – Brno Site
Control Laboratory (Veterinary) – Brno site
GLP Certificate
Certificate of Good Laboratory Practice
GCP Certificate
Certificate of Good Clinical Practice – Prague site
Certificate of Good Clinical Practice – Ostrava clinic
FDA Inspections
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.
If you’re unable to download these certificates, please contact us quinta@quinta.cz and we’ll be happy to email them to you.
Máte dotazy?
Kontaktujte nás přímo nebo pomocí níže uvedeného formuláře.
quinta@quinta.cz
+420 242 454 311
