Quinta-Analytica

Fully certified top-class services provider to the global pharmaceutical industry for over twenty five years.

Quinta is an innovative and trusted world leader in pharmaceutical analysis, R&D and clinical testing in both human and veterinary medicinal products.

Offering a range of services spanning the whole pharmaceutical spectrum, Quinta possesses unrivaled expertise across analytical services, clinical studies and more.

Proudly based in Central Europe, with partners in the EU, US and Asia, Quinta has 250 experienced in-house professionals ready to support your projects.

PHARMACEUTICAL ANALYSES

Validation of analytical methods, quality control, stability studies, batch release and more.

Clinical Testing

Our in-house Clinical Units have been operating since 2007, with over 300 BA/BE/PK studies completed.

BIOANALYTICAL Testing

Analytical services for pre-clinical studies up through Phase III, including statistical evaluation.

ANALYTICAL R&D

Development of analytical methods, impurities research, degradation studies, trace analyses and more.

BIOPHARMA ANALYSES

We provide complex analytical services for large molecules, including validation of bioanalytical methods in the GxP environment and method transfer.

Additional Services

API SOLUTIONS

Proudly based in Central Europe, with partners in the EU, US and Asia, Quinta has 250 experienced in-house professionals ready to support your projects.

NITROSAMINES

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

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.

AND MUCH MORE

It’s not an exhaustive list so if you don’t see what you need, contact us.

Questions?

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

Fully Certified

As holders of both GMP, GLP and GCP certifications for human medicinal products, and GMP certification for veterinary medicinal products, Quinta are 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 site

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.