Formulation

Design and optimization of formulations for dosage forms.
Specializing in lab development, pre-formulation, stability studies and design of packaging material, all within full GMP compliance.

Overview

‍Within our formulation activities, Quinta focuses on several basic areas where we offer, for example, the following services:

  • Problem solving and improvements of parameters during the development and production of the dosage form to achieve the desired quality of the product:
    • Stability of the products
    • Bioavailability of the active ingredient
    • Chemical and physical parameters of the dosage form
  • Laboratory development of dosage forms:
    • Pre-formulation, publication research
    • Design and formulation of the dosage form for the desired active ingredient (solid, semi-solid, liquid forms)
    • Design of a suitable packaging material for the given dosage form
  • Monitoring and evaluation of Stability Studies of the dosage form:
    • Accelerated stability
    • Natural stability
  • Within the scope of other activities and in full compliance with GMP requirements, we also offer activities in the following areas:
    • Collaboration on the preparation of manufacturing and approval documentation for the production of clinical batches.
    • Collaboration on the transfer of the technology for pilot (registration) batch size.
    • Collaboration on technology transfer for standard production batch size.
    • Collaboration on the validation of pilot and production batches. Design and preparation of validation protocols and validation reports.

Additional Services

API SOlutionS

Broad portfolio of active ingredients from reliable, established manufacturers, guaranteed by our expertise.

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Nitrosamines

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

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REGULATORY AFFAIRS

Expertise in helping to compile dossiers and drug registration processes.

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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.

GENERICS IN RUSSIA

Via our partnering CRO in Russia we can help you to perform clinical trials to apply for Russian MA.

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

Jiří Raška

Chief Commercial
Officer

David Dvořák

Business Manager
& Scientific Advisor

Pavel Pihera

Business Manager
& API Sourcing Manager
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.

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