Development of market launching strategy for medical products
Detailed elaboration of the strategy for bringing medical products to the market is the key to successful registration of a medicinal product.
According to the legislative acts adopted in the Russian Federation, only drugs registered for appropriate use on the territory of our country are subject to medical use. In accordance with Federal Law No.
- all medicines to be put into circulation for the first time in the Russian Federation;
- medicines registered earlier, but produced in other dosage forms in accordance with the list of names of dosage forms, in a new dosage with proof of its clinical significance and effectiveness;
- new combinations of previously registered medicines.
We carefully work out the necessary research plan to bring the drug to the selected markets, consult with specialists if necessary and promptly respond to requests from the Ministry of Health.
-
Evaluation of the drug role in the modern clinical practice
-
Establishment of the direction of drug usage in various nosologies
-
Analysis of the drug «niche» in the pharmaceutical market
ClinPharmDevelopment
Is an independent contract research organization successfully implementing preparation for and carrying out of clinical trials of all phases within the territory of Russia and EAEU countries.
We employ more than 30 people, including 6 PhD degree holders. All employees involved in trials have a university degree in medicine or pharmacy, GCP/GLP certificates, and broad experience of participating in clinical trials.
The company successfully cooperates with the centers of the Russian Federation for preclinical research that meet all modern requirements, localized in Moscow, St. Petersburg, Yaroslavl."
CPD has received permission from the Ministry of Health of Russia and is starting to conduct the clinical part of the bioequivalence study of a drug used in the treatment of inflammatory and degenerative diseases of the musculoskeletal system, pain syndrome from the spine (lumbago, neuralgia, myalgia,...
CPD employees have prepared a number of protocols and related documents for obtaining permission from the Ministry of Health of the Russian Federation to conduct bioequivalence studies of medicines.
Studies of a nootropic drug used in the treatment of diseases of the central nervous system...CPD has received permission from the Ministry of Health of Russia to conduct bioequivalence studies of a series of drugs.
Medications for the treatment of benign prostatic hyperplasia (dual 5α-reductase inhibitor) for the treatment of benign prostatic hyperplasia, treatment of dysuric disorders...CPD employees have prepared a number of protocols and other documents necessary to obtain permission from the Ministry of Health of the Russian Federation to conduct drug research.
Clinical studies Phase I of the original preparation of the Russian manufacturer, which has pronounced sorption...
A series of reports on completed clinical trials of bioequivalence of drugs was prepared in a short time.
Drugs highly selective direct factor Xa inhibitor, two dosages; contraceptive combination drug (two studies); an antidepressant used in the treatment and prevention of depression...The report of the phase III study of the Russian drug for the treatment of patients with COVID-19 was prepared and finalized in a short time.
This drug is intended for the treatment of a wide range of viral infections and is a purine nucleoside that acts as a competitive inhibitor of viral ...
CPD has prepared a protocol for a phase 3 study of a promising broad-spectrum drug used in the treatment of patients with coronavirus infection (COVID-19) of moderate and severe forms as part of standard therapy.
After the approval of the Ministry of Health of the Russian Federation, CPD will...
The recruitment of patients to phase III studies of a Russian drug for the treatment of patients with COVID-19 has been completed ahead of schedule.
This drug is intended for the treatment of a wide range of viral infections and is a purine nucleoside that acts as a competitive inhibitor of...