Service Title

Service Description

Pharmaceutical Testing

Research and development, analysis and testing, quality control and more.

Formulace

Návrh a optimalizace formulací lékových forem.

V rámci formulačních aktivit se naše společnost zaměřuje na několik základních oblastí, kde nabízíme např. tyto činnosti:
Řešení problémů a zlepšení parametrů v průběhu vývoje a výroby lékové formy pro dosažení požadované kvality produktu
   1) Stabilita přípravku
   2) Biodostupnost účinné látky
   3) Chemicko-fyzikální parametry lékové formy

Laboratorní vývoj lékových forem
   1) Preformulace, rešerše
   2) Návrh a formulace lékové formy pro požadovanou účinnou látku (pevné, polotuhé, kapalné formy)
   3) Návrh vhodného obalového materiálu pro danou lékovou formu

Sledování a hodnocení stabilitních studií lékové formy
   1) Zrychlené stability
   2) Přirozené stability

V rámci dalších aktivit a plně v souladu s požadavky GMP, nabízíme také činnosti v oblastech:
Spolupráce na přípravě výrobní a schvalovací dokumentace pro výrobu klinických šarží.
Spolupráce na transferu technologie pro pilotní (registrační) velikost šarží.
Spolupráce na transferu technologie pro standardní výrobní velikost šarží.
Spolupráce na validaci pilotních a výrobních šarží. Návrh a příprava validačního protokolu a validační zprávy.

Validation and transfer of methods

The introduction of the new analytical method is the most important step in the operation of the analytical laboratory and is therefore closely monitored by the project coordinator and the management of the laboratory. Transferring the method from a company to another lab is also thoroughly controlled and is usually supervised by our experienced analyst on site.

Transmissions and validation of the methods are in accordance with GMP rules and approved protocols. All experiments required for these work are conducted by our experienced analysts and supervised by the project coordinator. The reason is to ensure that the analytical method works accurately and correctly in all workplaces.

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Stability studies

Since its inception, Quinta-Analytica has been providing a complete implementation of a Stability Study with active substances and pharmaceutical forms. These studies are again carried out within the framework of the GMP and according to the ICH guidelines. Since 1999, more than 200 Stabilization Studies have been measured or under way in our company. We offer the following services:

  • Stability Protocols
  • Complete analytical testing
  • Large capacity for measuring stability samples
  • Stability modes:
    • 2-8 ° C
    • 25 ° C / 60% RH, 2 rooms, area 40m 2
    • 30 ° C / 65% RH, 1 room, area 16m 2
    • 30 ° C / 75% RH, 1 room, area 16m 2
    • 40 ° C / 75% RH, 2 rooms, area 32m 2
    • photostable box
    • transport study
  • Continuous and summary reporting of stability results.

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Analyses of highly potent substances

We use Highly Potent Substance Laboratory (HPSL) for high-potency analyzes. It consists of several laboratories, hygienic loops and is completely autonomous in terms of personnel and equipment. It can work independently of other projects, and with special regard to safety.Analyzes of highly active substances represent a large part of the capacity of separation of pharmaceutical analyzes and we have several years of experience with them.

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Quality control, release analyses

Quality control within GMP is an integral part of pharmaceutical production. Although Quinta-Analytica does not have a pharmaceutical product line, it owns a GMP certificate and a production license. This is why our company is approved for quality control and also for analytical testing of release testing. It is testing products destined for the EU market, which must be so-called "released" to EU countries.

Quinta-Analytica has been a well-established and established batch release testing company that has been manufactured outside of the EU - "import testing". We do this testing even for the world's largest pharmaceutical manufacturers.

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Support of formulation development

During the development of the dosage form, a large number of test batches are produced in which various important parameters such as active ingredient content, purity, water content, hardness, etc. have to be analyzed. Reliable and rapid analytical results are very important for the proper development of the dosage form. Quinta-Analytica is able to analyze a large number of such samples in time and at the appropriate quality thanks to the rapid and flexible planning of analytical work. Results reports can be requested in a quick, well-arranged spreadsheet form.

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Support of manufacturing process validation

Validation of the manufacturing process of the pharmaceutical form is one of the most important part of the manufacturing process under Good Manufacturing Practice (GMP). The manufacturing process must also be validated within this practice. A large number of samples are produced during the process, which must be analyzed by approved and validated methods. The capacity of analytical laboratories of a given pharmaceutical manufacturer sometimes has limited capacity, and in this case, Quinta-Analytica can help and analyze these samples.

Quinta-Analytica has many years of experience in this field, and many pharmaceutical forms in the world have been validated using our analytical services.

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Analyses of inhalation products

Quinta-Analytica provides testing of inhalation products administered via dry powder inhalers. Our special laboratory with controlled environment (temperature and humidity) performs analyzes of these products according to CL and Ph. Eur. monograph Preparations for inhalation 2.9.18 and 0671, Inhalanda.

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API Sourcing

Nabízíme

Další
služby

a poradenství

  • SVP Balení / Štítkování pro stabilitní studie a klinické testování
  • Audit Modulu 3
  • Kompilace IMPD
  • Monitoring studií

If you don't see what you need or have a question, get in touch with us!

  • Farmakovigilance
  • Regulatorní záležitosti
  • Registrace generik v Rusku
  • A další ....

Pokud nevidíte, co potřebujete, nebo máte otázku, žádný problém.
Náš obchodní tým vám rád pomůže!

Jiří Raška

Chief Commercial Officer

David Dvořák

Business Manager
& Scientific Advisor

Pavel Pihera

Business Manager
& API Sourcing Manager
Contact Us
clients

Testimonials

Our client loves us because of our quality work

Conpress is a great platform to anyone like who want to start buisiness but not get right decision. It’s really great place for new to start the buisness in righ way!

John Doe
Marketing Menager

Conpress is a great platform to anyone like who want to start buisiness but not get right decision. It’s really great place for new to start the buisness in righ way!

John Doe
Marketing Menager

Conpress is a great platform to anyone like who want to start buisiness but not get right decision. It’s really great place for new to start the buisness in righ way!

John Doe
Marketing Menager

Conpress is a great platform to anyone like who want to start buisiness but not get right decision. It’s really great place for new to start the buisness in righ way!

John Doe
Marketing Menager

Conpress is a great platform to anyone like who want to start buisiness but not get right decision. It’s really great place for new to start the buisness in righ way!

John Doe
Marketing Menager

Conpress is a great platform to anyone like who want to start buisiness but not get right decision. It’s really great place for new to start the buisness in righ way!

John Doe
Marketing Menager
It's the world's largest pharmaceutical exhibition, and we'll be there.
Learn more about the event or schedule a meeting with us.
It's the world's largest pharmaceutical exhibition, and we'll be there. Learn more or schedule a meeting with us.
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