We provide comprehensive services within clinical trials (Phase I). Clinical trials include the actual clinical part of a study followed by bioanalytical, pharmacokinetic and statistical evaluation. We specialise in bioequivalence studies (BE), but we are, of course, able to conduct various types of pharmacokinetic or pharmacodynamic studies according to the customer requirements.
Clinical trials are conducted in a fully-equipped facility with hospital beds where we provide all the necessary care and comfort to the subjects of the studies. The activities of the Department of clinical studies are directly connected to the Bioanalytical department, whose laboratories are equipped with state-of-the-art equipment, in particular with HPLC/MS/MS devices that can be used not only to determine active substances but also metabolites in different biological matrices. The measured analytical data are further processed by a team of professionals in the field of pharmacokinetics and statistical evaluations.
These departments are able to provide comprehensive services from the design of the study, through obtaining approvals of the Ethics commission and the State Institute for Drug Control, conducting the study itself to the compilation of the final report according to standard world requirements. All activities are conducted in close cooperation with the sponsor of the study and are performed within the Good Clinical Practice (GLP) or Good Laboratory Practice (GLP) systems under the supervision of the Quality assurance unit (QAU).
Quinta has many years of experience in pharmacokinetic/bioequivalence studies. A team of experienced professionals will provide a complete study on healthy volunteers, on a special population group of these volunteers, or on a population with special health conditions. The activities include:
Based on the requirements of the contracting authority, we conduct studies of various designs including statistical evaluation, for example:
Quinta-Analytica keeps a large pool of active healthy volunteers and on the request of the customer will also provide a special population of volunteers or a population of subjects with special health conditions. To be able to provide a well-defined group of subjects for the Phase I and II, we work closely with social and healthcare facilities. These subjects are used for bioequivalence/pharmacokinetic studies or Phase I and II studies. We will cooperate to provide toxicokinetic or other pharmacokinetic studies on animals. These target groups are:
We provide studies with different designs according to the requirements of the customer including consultations. These include for example the following studies:
We combine 20 years of experience in Europe with the understanding of Russian needs. In addition to Czech and English, our team can also communicate in Russian, which, together with the comprehensive understanding of the European, US and Russian regulatory requirements in combination with our extensive experience, makes our services very competitive, especially in GxP, analysis, and bioavailability/bioequivalence).
Since 2010, Quinta has conducted or participated in more than 25 bioequivalence studies in Russia. We have a joint venture with the registered office in Russia, which owns clinical BA/BE facility with 44 beds and in addition to our Prague laboratory, we also have a joint bio-analytical laboratory in Russia. Our Russian joint venture operates according to our own European working procedures adapted to the current Russian legal regulations. We continuously inspect and improve the performance of our Russian partners. We also cooperate with Russian partner workplaces in pre‑clinical studies (required now by Russian law). We have a general understanding of the Russian regulatory strategy in area of generics.
Quinta offers comprehensive services to companies focusing on the Russian generic market. Whether you seek assistance with regulatory submissions in Russia, want to conduct pre-clinical generic studies or require complete clinical and bioanalytical services (bioavailability/bioequivalence (BA/BE)), our R&D, regulatory and medical team can provide you with all the support you need.
We offer the following services in Russia (all the services are available in English and Russian):
In September 2010, the new Federal Law No. 61 "On Drug Circulation" came into effect in the Russian Federation. This law introduced a number of changes in the drug registration system. One of the most significant changes is the general requirement to conduct bioavailability/bioequivalence studies in Russia for all newly registered medicinal products for oral administration. This requirement has led to significant changes in the field of clinical trials in Russia: Since 2010, the requirement for the bioequivalence study to be conducted in Russia applies also to foreign companies regardless of whether they have already conducted these studies with the same medicinal product in other countries.
Even if the reference medicinal product is globally registered in the EU, US or other countries and its first bioequivalence study was conducted in the EU, Canada, USA, etc. with the same global original medicinal product as reference, the study should also be conducted in the Russian federation.
Each study is conducted in accordance with the standards of Good Clinical Practice (GPC) and Good Laboratory Practice (GLP). The Quality assurance and quality control unit (QAU) proceed according to internal regulations and monitors the compliance of each step from planning (study protocol), through the submission to the Ethics Committee and the State Institute for Drug Control, conducting the study and its documenting, to the compilation of the final report. All activities are conducted according to Standard operating procedures (SOPs) and the Study protocol.
The data recorded during the study, data transfers and the reports are submitted to 100% control by the Quality assurance unit before the final audit of the study.
The QAU staff will organize monitoring of the studies if they take place outside the premises of our clinical facility (Phase II to IV studies) and if the sponsor delegated this activity to our CRO. Monitoring of the studies is carried out in accordance with the legal regulations, the requirements of the customer and according to our SOP.
At the request of the other party, the QAU staff can conduct an independent GCP audit. The audit is carried out according to legal requirements and according to our SOPs.
Broad portfolio of active ingredients from reliable, established manufacturers, guaranteed by our expertise.
Based on isotopically labeled standards, our customizable in-house detection methods are available immediately.
Expertise in helping to compile dossiers and drug registration processes.
Oversight of participant health and correctness of treatments during clinical studies.
Monitoring of daily routine to detect unrecognized adverse events, plus assess and ensure drug safety.
Thorough dossier M3 data audit to ensure consistency and compliance with regulatory requirements.
Via our partnering CRO in Russia we can help you to perform clinical trials to apply for Russian MA.
As an EU based company we are well-placed to help create & develop your IMPD.
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