Early Phase I-IIa
MMA Research is Academic Research Organization (ARO) on the territory of Sofia, Bulgaria. The company was established for the purpose of management of Early phase – I/IIA.
The facilities for Early Phase studies are situated in Sofia, Bulgaria.
The medical writing is outsourced in Germany.
Phase I-IIA units – facilities
1. Unit – 21 beds /3 intensive beds / for Phase I/IIA
2. Unit /optional /- 6 beds for Phase I/IIA
● Area 200 m2
Phase I-IIA unit – team
●Prof. Dr. Vitan Vlahov is our official scientific consultant. Being the most prominent Key Opinion Leader in the field of Clinical Pharmacology Prof. Vlahov is the Honorary President of the Bulgarian Society of Clinical Pharmacology and Therapeutics with more than 30 years of experience in the clinical research area and over 160 clinical trials as investigator.
Prof. Vitan Vlahov is a former Head of the Department of Clinical Pharmacology at Medical University, doyen in the field of clinical trials in Bulgaria heaving experience since 1985.
●Principal investigator for Early phases, BE / BA is AAAAA – with experience in trials in Bulgaria since.
● Investigators, coordinators, pharmacists, research nurses .
The team periodically undergoes training for GCP.
Phase I-IIA unit – site management activities
● contracts’ negotiation with investigative teams and institutions/vendors;
● training of investigators, monitors and other staff
Phase I-IIA unit – services
●Examination area;
●Laboratory services;
●Synevo laboratory;
●Imaging diagnostic (CT, XRA, ECHO)
Phase I-IIA unit – control services
●Access control;
●Central clock;
●24/7 Emergency reception;
●24/7 Laboratory service;
●Continuous patient monitoring;
●Video, announcement and audio systems;
●Patient alarm;
● Temperature monitoring for all freezers and etc. systems
BE/BA
MMA Research is Academic Research Organization (ARO) on the territory of Sofia, Bulgaria. The company was established for the purpose of management of Bioequivalence/ Bioavailability studies.
The facilities for BE/BA studies are situated in Sofia, Bulgaria.
The medical writing is outsourced in Germany.
BE/BA units – facilities
1. Unit – 21 beds /3 intensive beds / for Phase I-IIA
2. Unit /optional /- 6 beds for Phase I-IIA
● Area 200 m2
BE/BA unit – team
●Prof. Dr. Vitan Vlahov is our official scientific consultant. Being the most prominent Key Opinion Leader in the field of Clinical Pharmacology Prof. Vlahov is the Honorary President of the Bulgarian Society of Clinical Pharmacology and Therapeutics with more than 30 years of experience in the clinical research area and over 160 clinical trials as investigator.
Prof. Vitan Vlahov is a former Head of the Department of Clinical Pharmacology at Medical University, doyen in the field of clinical trials in Bulgaria heaving experience since 1985.
●Principal investigator for Early phases, BE / BA is AAAAA – with experience in trials in Bulgaria since.
● Investigators, coordinators, pharmacists, research nurses .
The team periodically undergoes training for GCP.
BE/BA unit – site management activities
● contracts’ negotiation with investigative teams and institutions/vendors;
● training of investigators, monitors and other staff
BE/BA unit – services
●Examination area;
●Laboratory services;
●Synevo laboratory;
●Imaging diagnostic (CT, XRA, ECHO)
BE/BA unit – control services
●Access control;
●Central clock;
●24/7 Emergency reception;
●24/7 Laboratory service;
●Continuous patient monitoring;
●Video, announcement and audio systems;
●Patient alarm;
● Temperature monitoring for all freezers and etc. Systems
Medical Writing
MMA Research is Academic Research Organization (ARO) on the territory of Sofia, Bulgaria. The company was established for the purpose of management of Early phase I/IIA, Bioequivalence/ Bioavailability studies.
The facilities for Early Phase I/IIA, BE/BA studies are situated in Sofia, Bulgaria.
The medical writing is outsourced in Germany.
Medical Devices and Diagnostics
MMA Research is Academic Research Organization (ARO) on the territory of Sofia, Bulgaria. The company provides organization and site management services of clinical trials for Medical Devices and Diagnostics on the territory of Bulgaria.
Study team
● Investigators;
● Coordinators;
● Pharmacists
The team periodically undergoes training for GCP.
Site management activities
● MMA Research is organized according to the EU standards to coordinate the conduct of late phase protocols in outpatient population and in different indications.
● MMA Research coordinates clinical trials at hospitals in Bulgaria and could take over studies enrolling hospitalized patients.
Medical Projects
Medical projects in different directions:
● Renovation of the MMA Research building for early and late phase protocols of medicinal products and devices.
The aim is to renewed a medical structure on the territory of the city of Sofia, Bulgaria in accordance with local regulations and EU regulatory standards.
● Appropriate equipment of the MMA Research in accordance with the most modern medical standards in the world practice.
● Hospital construction project
MMA Research Ltd. will build a specialized hospital structure on the territory of the European Union for conducting early and late phases of clinical trials with the possibility for complete implementation of the study – design, monitoring, submission of centers, coordination activities. The hospital is focused on the introduction of modern innovative medical technologies and medical specialists with the application of unique medical approaches.
Investment
According to a contract prepared by our lawyers, there is a possibility for
financial investment in medical projects:
● Renovation of the MMA Research building
● Appropriate equipment of the MMA Research according to the peace of-art medical standards in the world practice;
● Hospital construction project
Building up a facility on the territory of the town of Sofia, Bulgaria in accordance to the regulatory standards of EU;
The new facilities will be organized in accordance to the guidelines for Good Clinical Practice of International Conference of Harmonization (ICH-GCP) and the national Laws and Regulations of Bulgaria.
Joint Projects
Development and execution of the following joint projects:
◙ A joint international project for a modern approach to building the base for the development of medical activity as the parties combine their capabilities in two main areas:
1. Structure for conducting of research activity in the field of clinical trials: MMA Research Ltd. and Medical Center Izgrev SMLLC
2. Structure for application of innovative diagnostic and therapeutic medical methods according to the requirements of the most modern world standards:
● Establishment of an orthopedic structure for application of innovative methodology. Teams of leading specialists in orthopedics and traumatology from Bulgaria have been involved in the joint activity. A readiness has been agreed to provide Bulgarian surgeons who can be trained in the methodology.
For the purposes of the project, it is necessary to build a hospital with a separate sector for orthopedics and traumatology. There is a suitable base in a prestigious area of Sofia.
● Establishment of an ophthalmological base for application of innovative methods.
● Modern diagnostic methods: laboratory, imaging diagnostics.
◙ An international project for a new approach to the production of food products using modern technology in research-controlled environment.
● The leading idea for establishment of joint venture between International Holding and Bulgarian Company for the opportunity to become a valuable TOP company in the world. This organization could be representative and multipliable in other countries on the model of what was created in Bulgaria..
1. Our strategy for development of the Bulgarian Company is expanding the existing structure with a basic direction, to reorienting to highly professional production of tomato powder without additives and based on Bulgarian high aromatic tomatoes as we rely on shorter terms of realization.
2.The second system for production of standard milk powder is developed to the based to Bulgarian milk from cow, goat and sheep. The possibility is created of expanding the existing structure on the territory of VITAL Ltd.
◙ Joint Israeli-Bulgarian project.
This project is as result of the signing of the Peace Agreement with Israel and the Gulf States (Saudi Arabia, Bahrain, Qatar).These new opportunities have opened to EU countries through Israel to the Arab Peninsula.
◙
1. Research and Development activities in:
● Investment projects and development of joint activities for new medical technologies, medicines, medical devices and equipment and technical facilities for medical treatment and rehabilitation;
● Innovative architectural and interior design of buildings for medical treatment and rehabilitation, including for the purpose of transfer of technologies;
●Supervision over Intellectual Property of the Parties in innovations and technologies during investment projects implementation.
●Supervision of author’s projects, investment projects
2. Management Consultation to Local and International Investment Projects for:
●Selection of methodology for research, test and development of medicines and devices of manufacturing companies and owners of know-how;
● Analysis and selection of technologies to be transferred;
●Decision-making for investment in innovations;
●Participation in attracting and management of investments;
●Participation in attracting investments for construction of facilities for technology transfer.
◙
1. Research and Development activities in:
●Development of Competency Centers for medical treatment and rehabilitation;
●Joint activities with owners of new medical technologies, medicines, medical devices and equipment and technical facilities for medical treatment and rehabilitation;
●Supervision over Intellectual Property of the Parties in innovations and technologies during investment projects implementation;
●Supervision of author’s projects, investment projects.
2. Consulting the management of manufacturing companies and
Owners of know-how for:
●Analysis and selection of technologies to be transferred;
●Decision-making for investment in innovations
Consulting Services
1. The registration of a medical device as a food supplement, according to the European legislation and the future distribution and sale of the medical product.
2. The transfers of medicines, medical devices, including to third countries.
3. The organization of medical structure implementing an innovative practice in the following areas:
●Project for building up a facility for implementation of surgical technique for elongation of extremities on the territory of Bulgaria in accordance to the regulatory standards of EU; Provision and/or training of a team of specialists in orthopedics and traumatology for implementation of innovative surgical technique for elongation of extremities;
● Establishing the scientific research activities and organization of the activities of the MMA Research Ltd. and Medical Center Izgrev SMLLC for clinical trials of medicinal products and devices.
Partner ■ International Partner
4. Creation of strategy for development of Foodstuffs Company on the territory of Bulgaria with the basic directions of reorientation to highly professional production of tomato powder without additives and based on Bulgarian high aromatic tomatoes as is rely on shorter terms of realization.
● Providing modern technical equipment and financial resources according Agreement for joint venture with strategic partner.
● Application of new technologies for food production in research-controlled environment.
●Ensuring markets in third countries.
This organization could be representative and multipliable in other countries.
Nikola Ramshev, MD Manager of MMA Research is Authorized representative of Vital Ltd. as well as a consulting party of the agreement.
5. The possibility of Foodstuffs Company to produce
a protein powder (sour milk powder).
The possibility of Foodstuffs Company to produce a protein powder.
Created system for production of sour milk powder is developed to the based to standard Bulgarian sour milk from cow, goat and sheep.
Our sour milk powder containing 18% vegetable protein and high level of Lactobacillus bulgaricum.