Full cycle (development, preclinical and clinical studies, preparation of registration dossier and registration, synthesis of pharmaceutical substances, development of finished dosage form) of works and services necessary for the creation of medical applications for the pharmaceutical industry in accordance with international standards of good practices (GLP, GCP, and GMP).more
Development of innovative capacity and research and development sector
Development, conducting preclinical and clinical studies, preparation of registration dossier and registration, synthesis of pharmaceutical substances, development of finished dosage form and other services necessary for the creation of drugs and medical products.
Full cycle (development, preclinical and clinical studies, preparation of registration dossier and registration, synthesis of pharmaceutical substances, development of finished dosage form) of works and services necessary for the creation of medical applications for the pharmaceutical industry in accordance with international standards of good practices (GLP, GCP, and GMP). Creation of pilot production of medicines on the basis of sites of the Moscow Institute of Physics and Technology and research Centers of RAS in Chernogolovka and G. Pushchino and a number of other scientific institutions for the biopharmaceutical industry in accordance with international standards (GxP).
PCSC is a service organization that performs the functions of the Cluster Project Office, including media relations, market analysis and marketing, customer engagement, performs the necessary procurement research - reagents, consumables, etc., maintains customs declaration procedures and logistics of biosamples and studied drugs, provides regulatory support; conducts an assessment of the required amount of research; develops and writes medical documentation; supports accreditation of test sites.
The Research Institute of Medical Primatology is the sole primatology center in Russia and the largest one in Europe. The Institute has the Laboratory of molecular biology and genetics; Laboratory of toxicology with the pathomorphology and morphometry department; Laboratory of Biochemical Studies; Laboratory of Cancerogenesis; Laboratory of pharmacology and physiology; Chemical-analytical department; Laboratory of virology microbiology with the immunotoxicity and allergenicity department; Laboratory of molecular visualization; Laboratory of cell technologies with the cytotoxicology department; Laboratory of embryogenesis and Monkey nursery with the department of SPF animal stock and biological models.
JSC "BIS" ("Biological research and systems") manufacturing pharmaceutical company. Since 2013, the company has GMP certificate and specializes in the production of medicines, pharmaceutical substances obtained by chemical synthesis. The range of products include 10 types of API and dosage form of drugs including Decaline chloride, Мезодиэтилэтилендибензолсульфонат, Sibutramine, Povidone-Iodine, Prazosin, Triadization, Hydroxyphenylpropionic acid+Hydracarina acid, Selenium sulfide and Pipofezine.
"BTech Laboratories Rus" research company. Competences of the company include: Synthesis and analysis of pharmaceutical substances (FS) and finished dosage forms (SFF) including synthesis methods, physico-chemical properties, activity and toxicity in vitro. Pathogenetic evaluation of diseases, pharmaco-genomics and biomarkers. Pharmacological correction of diseases: bio-informatics of therapeutic effects, means of drug delivery, changing the characteristic phenotypic symptom of the disease. Screening of bioactivity: reverse virtual screening, pharmaco-transcriptome and -proteome analysis, safety of modulation of target activity, re-profiling of drugs.
Test Laboratory “Test” is specialized on laboratory quality control of products and services including tests of food products, animal feeds, production raw materials, water for safety and quality values; Veterinary diagnostics; Studies (development of test systems for microtoxin analysis); Development and implementation of analytical methods; Training and consultations on laboratory arrangements; Production of reference samples.
ISMAR – the dynamic, multiprofile, private contract research organization (CRO), provides expert services to pharmaceutical and biotechnological companies in development and arrangement of II-IV phase drug clinical studies in Russia, Ukraine and other CIS countries. Clinical studies are carried out in accordance with ICH GCP in therapeutic areas: pulmonology, cardiology, gastroenterology, oncology, neurology, hematology, dermatology, otolaryngology, pediatrics, orthopedics, metabolism disorders/endocrinology, autoimmune diseases.
The Pushchino State Institute of Natural Sciences prepares specialists in fundamental and applied biotechnology: - Development of new drugs and their manufacture technologies. Preclinical toxicological studies of safety of biomedical drugs in accordance with the international GLP standard and investigation of their pharmacological action
The Clinical Site at the Hospital of the Pushchino Research Center is accredited for I-IV phase clinical studies to establish safety and tolerability of drugs in healthy volunteers; to select optimum drug dosages and courses, and vaccination schemes in healthy volunteers; to establish safety and efficacy of drugs in patients; to expand indications for medical use, and take part in scientific work on development, justification and assessment of efficacy of available and innovative drugs. The Site has the designated unit for 20-45 beds, base of healthy volunteers and full-time medical personnel certified in compliance with ICH GCP R2.
The Clinical site at the Hospital of the Chernogolovka Research Center is accredited on III-IV phase clinical studies to establish safety and efficacy of drugs in patients; to expand indications for medical use, and takes parts in scientific work on development, justification and assessment of efficacy of available and innovative drugs. The site personnel consists of 480 highly professional specialists.
The Moscow Institute of Physics and Technology prepares specialists in innovative pharmaceuticals, medical equipment and biotechnology, bioinformatics and systemic biology, molecular and cellular biology and translation medicine, molecular physiology and biophysics, managing and information systems, physical – chemical biology and biotechnology, etc. The investigations in MIPT cover the wide range of areas of theoretical and experimental physics, power industry and biomedicine, chemistry and applied mathematics, development of innovative drugs and agrobiotechnologies. MIPT has the extensive fleet of metrological analytical and technological equipment which allows to carry out intensive investigations in such areas of science, technology and equipment development as the industry of nanosystems and materials, information –telecommunication technologies, metrology of low size systems, etc.
The Institute of Theoretical and Experimental Biophysics carries out fundamental and applied studies in theoretical and experimental biophysics. Nowadays, the institute consists of 23 laboratories in the areas – Structure and functions of biomolecules and supramolecular complexes, proteomics, catalysis; Cell biology, theoretical fundamentals of cell technologies; Biophysics, radiobiology, mathematical models in biology, bioinformatics and Biotechnology. Generation of tissue engineering biomaterials, diagnostic biological microchips, 3D printing are the priorities.
The Institute of Problems of Chemical Physics operates with 10 research departments, 80 laboratories and scientific groups in which over 1100 persons work including 6 RAS academicians, 3 corresponding members of RAS, as well 109 Doctors and 288 Candidates of Sciences. The works are made in the Institute in the following main areas: general problems of chemical physics, structure of molecules and structure of solid bodies, kinetics and mechanism of complex chemical reactions, chemical physics of combustion and explosion, chemical physics of polymer formation and modification processes, chemical physics of biological processes and systems, chemical material engineering.
The Institute of Physiologically Active Substances carries out the entire complex of studies on development of physiologically active compounds, from computer modeling of structures and properties of chemical compounds to their synthesis and investigation of biological properties. The Institute has three specialized divisions: department of the computer molecular design, department of the fundamental organic chemistry, department of medical and biological chemistry including areas – Synthetic organic and element organic chemistry; Investigation of biological properties of chemical substances and mechanisms of their exposure on functioning of biological systems and Computer molecular design. Numerous research and development works by IPAS have been widely acknowledged both in Russia and abroad.
The Institute of Bioorganic Chemistry develops and manufactures the most advanced drugs of protein origin and generates various types of agricultural biotechnology and biofarming based on transgenic plants. The institute has the complex of unique divisions: Laboratory of biological tests, Research and Production Enterprise “Nursery for Laboratory Animals” and the Complex of fire waste disposal. Since 2005, the Laboratory has been accredited by AAALACi, since 2013 has been internationally acknowledged as compliant with GLP OECD, since 2017, the Laboratory is the partner of JSC “Russian Expert Center”. The nursery has been accredited by AALACi since 2004, ISO 9001 since 2007.
The Institute of Biochemistry and Physiology of Microorganisms carries out fundamental and applied studies on microorganism structure and functions including – Research of fine structure and biochemical functions of a microbial cell; Development of theoretical fundamentals of growth management, development and metabolism in microorganisms; Microbiological transformation of organic substances (steroids, amino acids, etc.); Use of microorganisms for biosynthesis of biologically active substances and other essential compounds (vitamins, enzymes, antibiotics, alkaloids, etc.) and Collection of the microbial variety.
PCSC service organization, performs the functions of the project office of the cluster, including media relations, market analysis and marketing, attracting the customer, carries out the necessary research purchases - reagents, consumables, etc., conducts customs Declaration procedures and logistics of biological samples and studied drugs, provides regulatory support, evaluates the required amount of research, development and writing of medical documentation, supports the accreditation of test sites.
142290, Moscow region, Pushchino, prospect Nauki d. 3, office 409
+7 (916) 226 25 48