Medical expertise - Services

The Institute will offer a variety of services intended for residential, commercial and industrial sectors, as well as for Governments.

Quality Control Services

 

Pharmaceutical Products

  • Physico-chemical tests: content, structural and stability analyses, according to USP, BP, FP and official protocols,
  • Analysis and assessment of the active ingredients,
  • Microbiological quality control including bacteriological, fungal and viral tests,
  • Bioavailability, innocuity and other normative studies,
  • Stability studies.
 

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Cosmetics

  • Reglementary quality control, using USP, BP, FP protocols,
  • Analysis and assessment of the active ingredients,
  • Microbiological quality control including bacteriological, fungal and viral tests,
  • Studies of allergenicity and acute corrosive skin reactions,
  • Stability studies.

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Food

 

  • Analysis and assessment of the nutritional facts values,
  • Microbiological quality control including bacteriological, fungal and viral tests,
  • Identification and determination of added synthetic colorants, antibiotic and hormone contents,
  • Allergens content determination using AOAC protocols,
  • Identification of genetically modified organisms (GMO),
  • Stability studies.

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Industrial Products

  • Safety, effectiveness and toxicity control.

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Regulatory Services

 

Reglatory Evalution and Certification of New Products

  • Drugs
  • Cosmetic Products
  • Biochemical Products
  • Food

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Evaluation of the Performance of Accredited Laboratories

These evaluations will focus on:

  • Good Manufacturing Practice (GMP),
  • Good Laboratory Practice (GLP),
  • Good Clinical Practice (GCP),
  • International Standard Organization (ISO) practice,
  • International Conference on Harmonization (ICH) practice,
  • Technical performance of the accredited laboratories,
  • Auditing.

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Health Care Services

 

Biomedical Analyses – Human & Veterinary Diagnostics

  • Viral and parasitic diseases diagnostic using biochemical, microbiological and immunochemical methods,
  • Tumors and auto-immune diseases diagnostic using immunohistochemistry probes and other non invasive radio-imaging methods including NMR scan,
  • Allergies caused by mold, dust mites, food and drugs, using different specific tests kits,
  • Epidemic and pandemic detection and surveillance, in close collaboration with the CDC (Center of Disease Control) of the NIH (National Institute of Health) of the USA, Health Canada and the WHO. The Institute will provide and foster epidemic and pandemic alerts in the sub-region of south-easthern Europe.

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Clinical Studies

Clinical assays on humans and animals are carried out in compliance with WHO and ICH (International Conference on Harmonization) GCP (Good Clinical Practice) guideline requirements, and will include:

  • Site selection,
  • Subject selection and health enrollment,
  • Effectiveness tests,
  • Bioavailability test,
  • Innocuity test,
  • Data handling,
  • Application for regulatory certification of new biomedical products.

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Biomedical-Legal Expertise

                                                                                          The Institute offers legal expertise in pharmaceutical, cosmetic, biomedical, food, environmental and industrial scientific and technological issues. This service is based on over 26 years of relevant expertise of BioMedco's legal experts recognized at most of the Courts in the province of Quebec and other canadian provinces.

  • Consulting,
  • Biomedical-legal and analytical expertise,
  • Cons-expertise,
  • Writing legal reports,
  • Testemony in court.
           

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Experimental Medicine Center (EMC)

                                                                                                                                Teodor Burtea, MD.                                                                                                                                                                                                                                                                                                                                                         The Experimental Medical Center (EMC) of the Institute is conceived as a private prestigious health care institution composed of specialized laboratories and clinics, demonstrating medical expertise in the area of medical diagnostics and treatment. These services are offered via the medical expertise of highly skilled doctors and by biomedical experts working within the Institute and by their colleagues coming from different parts of the world. These experts will be selected and invited on a contractual basis by the EMC. In addition to upholding the highest international standards and protocols, the EMC will expand its medical expertise by favouring the development of experimental and leading-edge diagnostics and treatments. These will be developed by the Institute’s scientific experts and health care institutions throughout the world. The EMC will treat ambulatory patients from Montenegro as well as patients with new or poorly known diseases from nearby countries. The Institute will also offer innovative and effective experimental medical treatment for complex diseases. The EMC will be adequately equipped with state of the art technologies necessary to carry out its professional activities. The EMC aims to become the preeminent health care institution and research authority in the region, responding to the most challenging health care needs of modern European societies. The Institution is also dedicated to the post graduate education and specialization of young and promising biomedical experts and medical doctors.                        

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Healthcare Industry Relations and Personalized Medicine

Department of Strategic Directions:

  • Establish and design the Institute's Pharmaceutical Strategy for 2011-2015.
  • Liaise with pharmaceutical, medical devices and other health technology manufacturers operating or interested to establish commercial activities in the region; evaluate and promote collaborations, co-marketing or in-licensing opportunities.
  • Provide independent expert advice to Healthcare Authorities of Montenegro on pricing and Pharmacoeconomic evaluation of healthcare interventions drugs, medical devices, teleHealth.
  • Design and execute research projects targeting unmet medical needs and interventions with impact on quality of care in Montenegro. The Institute's on-site laboratory will operate as Central Laboratory for all research projects, ensuring quality control and compliance with GLP, relevant norms and regulations.
  • Develop and implement the concept of post-marketing surveillance for newly approved drugs in Montenegro to ensure and monitor public safety and pharmacovigilance.
On the basis of the above experience, the Institute should add to its Mission:
  • Optimization of healthcare resources utilization through pharmacoeconomic evaluation, quality of care improvement initiatives and health technology interventions,
  • Collaboration with the Ministry of Health for the implementation of the Strategy for the Development of Health Care System by harmonizing evidence based medicine interventions, point-of-care diagnostics, teleHealth and implementation of personalized medicine concept.

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Environmental Analyses

 

Water Biology

Water Biology activities include: Microbiological, parasitic and toxicological quality control of tap drinking water and boottled  water, industrial waste, urban sewage, rivers, lakes, public and private pool water. Studies of sea water The Adriatic coast of Montenegro is characterized by unique geographic aspects and was home of several civilizations since the ancient time. On its length of about 200 km one can enjoy a continuous chain of most beautiful public and private beaches in the world.

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Drinking Water

                                                                                                                                          Drinking water has become a vital concern of most modern societies throughout the world. The manufacturing, transportation, commercialization and continuous quality control are in direct association with the health of global population. Our sampling procedures are in accordance with requirements of North America and obtained results are compared to the strictest norms of USA, Canada, Japan and Scandinavian countries.

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Lakes and Rivers

Water analysis of numerous lakes and rivers are performed by the Institute's laboratories for standard quality controls.

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Public Swimming Pools and Beaches

As its founding company BioMedco, the Institute will maintain active involvement in longitudinal scientific studies and quality control of the water of public swimming pools and beaches.

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Sea Water

The Institute practices the protection of recreo-touristic attractions of Montenegro's Adriatic cost of numerous beautiful beaches by follow up os sea water quality.

External link: Montenegro's Adriatic coast www.morskodobro.com

 

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Indoor Air Quality (IAQ)

                                                                                                                                                                                                IAQ testing and monitoring becomes an essential preventive measure for the health protection in living and working environment. With the beginning of the energy crisis, four decades ago, indoor air quality has drastically deteriorated due to the modern urbanization characterized by construction of mechanically ventilated hermetic buildings. This deterioration affects progressively the health of the general population and raises great concern for all modern society. The Institute provides full range of indoor air quality testing for residential, commercial and industrial sectors, according to the pertinent scientific requirements and the ASHRAE norms, by our experts who are themselves ASHRAE members. Our commercial IAQ activities (American Society of Heating, Ventilation and Air Conditioning Engineers) are combined with graduate study programs on the impact of microbiological and chemical contaminants on human health. These programs are carried out at our representative office in Montreal in collaboration with the University of Montreal. IAQ services involve:

  • Indoor air and surface dust sampling for  microbiological, chemical, physico-chemical and toxicological studies,
  • Microbiological and physico-chemical studies   of heating, ventilation and air conditioning (HVAC) systems,
  • Indoor air monitoring for thermal comfort and mechanical performances of HVAC systems,
  • Microbiological, chemical, physicochemical and toxicological analyses of the collected samples. Some of these tests are performed      either on the site, by direct instrumental reading, or in our laboratory following sampling procedure
  • Analyses of mites and other insects,
  • Analyses of asbestos fibers in indoor air, surface dust and construction material.
  • Troubleshooting of microbiological and chemical contamination problems of indoor environment, as well as balancing of HVAC system to meet the ASHRAE norms and regulation requirements,
  • Studies of the impact of indoor environment on health by specifically designated biomedical protocols.

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Fighting Mold, Microbiological and Physico-chemical Polutants and Allergens in Indoor Environment

  • Microbiological and physicochemical assessment of indoor environments (residential, commercial and industrial)
  • Decontamination of mold-contaminated buildings
  • Decontamination of allergenic insect-contaminated buildings
  • Physicochemical decontamination of buildings from allergens and other chemical products.
Melting snow, abundant rain and ground water leaks are often the major causes of floods and sewage reversal, and consequently, of the microbiological and chemical contamination of residential houses and commercial or industrial buildings. The water infiltrates from the outside, submerging the building floors or ceiling, can contain or favors the proliferation of a significant number of microorganisms which are transported and dispersed in the interior of the affected building by the air velocity. The microorganisms, such as bacteria, molds and viruses, coming from contaminated environments may be introduced into the human body by ingestion, inhalation or direct contact, resulting in a variety of health problems such as allergic reactions, respiratory disorders (asthma), acute infections and chronic diseases, among the sensitive people, especially children, elderly and immunocompromised individuals. Flood, a natural disaster which occurs very often on the territory of Montenegro may also contribute to the microbiological contamination of human habitats. In the absence of decontamination measures, microorganisms will continue to proliferate and contaminate the interior environment, causing health problems to the exposed sensitive people. When water is put in contact with walls, it infiltrates and spreads within porous construction materials (wood, drywall, insulating wool...). Fast drying of these materials will prevent the further diffusion of water. However, simply drying these materials will not eliminate microorganisms and/or bad odors. If the soaked floor or wall structures are not removed and surfaces not decontaminated, microorganisms will always be present in the interior. When environmental conditions are favorable, these micro-organisms will proliferate, bad odors will be more easily perceptible and health problems of exposed people will worsen. Our Environmental Building Laboratory offers a complete range of services for the decontamination of industrial, commercial and residential buildings which guarantee effective microbial and chemical decontaminations, elimination of bad odors, resulting in a pleasant and healthy environment. Our technical team also ensures a microbiological and chemical decontamination service for the HVAC systems, the furniture and appliances, equipments and goods inside the buildings. After the decontamination procedures, our experts ensure its efficacy by carrying out appropriate verification analyses. At the end of the process, the client receives a Certificate of Environmental Conformity for the decontaminated building. The general decontamination procedures involves:
  • Evaluation of the environmental situation of the site (without charge)
  • Action plan of decontamination including a detailed description of the works to be done and their cost (without charge)
  • Microbiological and physicochemical assessments of indoor environments (residential, commercial and industrial)
  • Preliminary decontamination of the buildings which is carried out in order to render the ambient air inoffensive for the health of the users and the technicians involved in the decontamination procedures
  • Final decontamination of the buildings from the contaminating microbial flora, allergenic insects, chemical allergens and other toxic products
  • The effectiveness of these procedures is evaluated by appropriate sampling and analyses
  • Issuance of a Certificate of Environmental Conformity for the building.
All work is carried out by our team of experts (environmental technicians, microbiologists, biochemists, industrial hygienists, engineers and doctors) and verification of efficiency of decontamination analyses are performed by appropriate analysis in our laboratories equipped with state-of-the-art technology. Moreover, they are members of ASHRAE, of AMQ, of OCQ and other professional organizations. Their professionalism has earned them the trust and respect of insurance companies, all governments' levels, school boards, hospital boards, commercial and office building administrators, Indian reserves, detention building administrators, private residential sectors and other categories of buildings.      

Aspects of Our Environmental Building Laboratory

   

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Soil Analysis

  • Analysis of pesticides and herbicides
  • Toxological analysis by bioassays.

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Scientific Survey of Environment

Hygiene control of the industrial buildings according to existing EU standards Control of waste emission in the form of gases, liquid and solid pollutants Control of sewage pollution in urban areas Biological studies of the impact of certain sources of pollution including public dumps and environmental areas contaminated with microbial, parasitic and toxicological agents on the quality and length of the life of Montenegrin population.

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National Parks Studies

  • Montenegro has four national Parks with distinct ecosystems:
  • Biogradska Gora,
  • Lovcen,
  • Durmitor, and
  • Skadarsko lake.
  • The Institute is planning to continuously protect national parks by appropriate scientific studies and elaboration of preventative policies.

External link: for more information about these parks, click below to visit Montenegro's tourism website: www.visit-montenegro.com

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Building Decontamination

 

Fighting Mold, Microbiological and Physico-chemical pollutants and Allergens in Indoor Environments

  • Microbiological and physico-chemical assessment of indoor environments (residential, commercial and industrial),
  • Decontamination of mold-contaminated buildings,
  • Decontamination of allergenic insect-contaminated buildings,
  • Physicochemical building decontamination of allergens and other chemical products.
Melting snow, abundant rains and ground water leaks are often the major causes of floods, sewage reversal and, consequently, of the microbiological and chemical contamination of residential houses and commercial or industrial buildings. The water infiltrates from the outside submerging the building floors or ceiling and can contain or favour the proliferation of a significant number of microorganisms. These microorganisms are transported and dispersed in the interior of the affected building by the air velocity. The microorganisms, such as bacteria, molds and viruses, coming from contaminated environments may be introduced into the human body by ingestion, inhalation or direct contact. Exposure to these harmful microorganisms can result in a variety of health problems such as allergic reactions, respiratory disorders (asthma), acute infections and chronic diseases. Children, the elderly and individuals with compromised immune systems are particularly at risk. Floods occur very often in Montenegro and can also contribute to microbiological contamination of human dwellings. In the absence of building decontamination measures, microorganisms will continue to proliferate and contaminate the interior environment causing health problems for sensitive people exposed to them. When water comes in contact with walls, it infiltrates and spreads within porous construction materials such as wood, gyprock, and wool insulation. Fast drying of these materials will prevent the further diffusion of water. However, it will not eliminate microorganisms and/or bad odours. If the soaked floor or wall structures are not removed and surfaces not decontaminated, microorganisms will always be present in the interior. When environmental conditions are favorable, these micro-organisms will proliferate, bad odours will become more readily perceptible and health problems of those exposed will intensify. Our Environmental Building Laboratory offers a complete range of services for the decontamination of industrial, commercial and residential buildings. These services guarantee effective microbial and chemical decontamination, elimination of bad odours, resulting in a pleasant and healthy environment. Our technical team also ensures microbiological and chemical decontamination services for HVAC systems, furniture, appliances, equipment and goods inside buildings. After the building decontamination procedures have been conducted, our experts ensure their efficacy by carrying out appropriate verification analyses. At the end of the process, the client receives a Certificate of Environmental Conformity for building decontamination. The general building decontamination procedures involve:
  • Evaluation of the environmental situation of the site (without charge),
  • Decontamination action plan including a detailed description of the work to be done and its cost (without charge),
  • Microbiological and physicochemical assessments of indoor environments (residential, commercial and industrial),
  • Preliminary building decontamination is carried out in order to render the ambient air inoffensive for the health of the users and the technicians involved in the decontamination procedure,
  • Final building decontamination of the contaminating microbial flora, allergenic insects, chemical allergens and other toxic products
  • The effectiveness of these procedures is evaluated by appropriate sampling and analyses, and
  • Issuance of a Certificate of Environmental Conformity for the building.
All work is carried out by our team of experts (environmental technicians, microbiologists, biochemists, industrial hygienists, engineers and doctors) and the accuracy of the decontamination analyses are measured in our state-of-the-art laboratories. Moreover, our experts are members of ASHRAE, of AMQ, of OCQ and other professional organizations. Their professionalism has earned them the trust and respect of insurance companies, governments at all levels, school boards, hospital boards, commercial and office building administrators, Indian reserves and detention building administrators. Our experts also conduct analyses of private residences and other categories of buildings.

Sampling process in air duct

 

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Environmental Protection and Management

 

Environmental Protection

 

  • Montenegro possesses the highest amount of rainfall per square meter in all Europe and the longest underground river in the world. This exceptional environment has made natural habitats for a variety of unseen species of plants, birds and animals.
  • The country also has an unique geographical setting that shows a sea with beautiful beaches, rivers with the deepest canyons in the world, just after those of Colorado in the USA, giant and magnificent mountains surrounding glacier lakes and dense forests filled with unique and fascinating species of indigenous and alpine plants.
  • The Institute plans to protect this unique world's heritage through appropriate scientific studies and elaboration of protective policies.

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Foundation for Biomedical Research “Sveti Vasilije Ostroski”

External link: http://www.visit-montenegro.com/ostrog-history.htm

The scientific research activities will be continuously supported by the funds raised by the Foundation for Biomedical Research "Sveti Vasilije Ostroski" (St-Vasilie of Ostrog). This non profit oriented Institute will collect donations from private and public sectors, from governmental institutions, as well as from donating charitables organizations and international agencies.

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Quality Control Services

Pharmaceutical ProductsCosmeticsFoodIndustrial Products

Regulatory Services

Reglatory Evalution and Certification of New ProductsEvaluation of the Performance of Accredited Laboratories

Health Care Services

Biomedical Analyses – Human & Veterinary DiagnosticsClinical StudiesBiomedical-Legal ExpertiseExperimental Medicine Center (EMC)Healthcare Industry Relations and Personalized Medicine

Environmental Analyses

Water BiologyDrinking WaterLakes and RiversPublic Swimming Pools and BeachesSea WaterIndoor Air Quality (IAQ)Fighting Mold, Microbiological and Physico-chemical Polutants and Allergens in Indoor EnvironmentSoil AnalysisScientific Survey of EnvironmentNational Parks Studies

Building Decontamination

Fighting Mold, Microbiological and Physico-chemical pollutants and Allergens in Indoor Environments

Environmental Protection and Management

Environmental ProtectionFoundation for Biomedical Research “Sveti Vasilije Ostroski”