QUINTA-ANALYTICA

Pharmaceutical GxP-certified CRO for analytical development & QC, clinical studies and bioanalysis

Quinta services

Full-service CRO for small molecules, biologics and biosimilars, including human & veterinary IMPs

From BE/BA/PK studies to GLP/GCP bioanalysis and GMP QC with analytical R&D and CMC support

Central Europe hub (Prague/Brno/Ostrava) with global delivery under GxP quality systems

PHARMACEUTICAL ANALYSES

Validation of analytical methods, quality control, stability studies (incl. HAPIs), GMP batch release and more.

Clinical Testing

In-house BE/BA/PK studies in two clinical units, with over 300 studies completed.

BIOANALYTICAL Testing

GLP/GCP bioanalysis for preclinical & clinical studies up through Phase III, including statistical evaluation.

ANALYTICAL R&D

Method development/validation, impurities research, degradation studies, trace analyses, nitrosamine analysis and more.

BIOLOGICS QUALITY CONTROL

Characterization, GxP validation of bioanalytical methods, method transfer, cell-based assays for biologics & biosimilars.

Additional Services

NITROSAMINES ANALYSIS

Based on isotopically labeled standards, our customizable in-house detection methods are available immediately.

More Info

MONITORING OF STUDIES

Oversight of participant health and correctness of treatments during clinical studies.

PHARMACOVIGILANCE

Monitoring of daily routine to detect unrecognized adverse events, plus assess and ensure drug safety.

MODULE 3 AUDIT

Thorough dossier M3 data audit to ensure consistency and compliance with regulatory requirements.

IMPD COMPILATION

As an EU based company we are well-placed to help create & develop your IMPD.

Questions?

Our Sales team is ready to help: sales@quinta.cz

Fully Certified

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.

More about Quinta

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Questions?

Please use the contact details or form below.

quinta@quinta.cz

+420 242 454 311

    For general and business contact only. To register as a volunteer for clinical studies (CZ nationals only) or speak with our clinical department, please visit here.