Interesting portfolio of active ingredients from reliable and approved manufacturers guaranteed by our company.
There are thousands of API manufacturers in the world and while some provide first-class substances, others have substances of not very satisfactory quality. Quinta cooperates with certified and trusted manufacturers of substances from all around the world and guarantees the quality of the substances in their portfolios. We focus on specialty products, i.e. the niche API. Since Quinta also employs a number of Qualified persons, we are able to, if requested to do so, inspect and perform a quality audit at the production site in compliance with complete GMP rules.
Our customers can therefore rely on the fact that we offer only APIs of the highest quality and from reliable manufacturers. Because most of the API manufacturers with which we collaborate develop their own APIs, we are also able to offer an interesting portfolio of products under development, the so called pipeline list. These are substances that are not yet even on the market as generics, but API manufacturers already work on their development so that the manufacturers of the final medicinal products can prepare for a marketing authorization request well in advance before the patent protection of the original drug expires.
Thanks to its knowledge of the drug market, Quinta is able to find, audit, approve and deliver the required API in the required quality and time. The active substances or also the active pharmaceutical ingredients (APIs) are an essential part of each medicinal product. If the quality of the API is inadequate, neither the final drug (FDF) will be expected to meet the required specification because the API simply determines the quality of each product.
If you would like to secure a substance, do not hesitate to send us your request!
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.
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:
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.
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.
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.
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.
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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