About Histros Ziviltechniker Ges.m.b.H.
Special authorizations are granted by the Republic of Austria to Histros Ziviltechniker Ges.m.b.H., which is subject to the Austrian Civil Technician Act. The company is led by Mr. Lukas Glaser, who is a Chartered Engineering Consultant for Food- and Biotechnology. Thus the company can refer to the following authorizations for its specialization:
✔ Function as "Person of Public Trust" acc. to the Austrian Code of Civil Procedure
✔ Right to represent clients at competent authorities and at court
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Right to conduct the organizational and commercial management of projects
✔ Right to provide consultancy services in all aspects of its specialization
✔ Right to act as mediator and trustee
✔ Right to use the coat of arms of the Republic of Austria
Scope of Services
✔ Consultancy for Drug Regulatory Affairs with consideration of Pharmaceutical Quality Management
✔ Consultancy for the International Trade of FMCG-Products
The offered services are designed to provide support across borders and standards, which are specific for different economic areas. The geographic focus is set on Austria and the CEE-region.
About the Managing Director:
Dipl.-Ing. Lukas Glaser, M.A.
Two major interests form the passion of Lukas Glaser:
The regulatory and quality environment for the development of pharmaceutical and FMCG-products and on the other hand their distribution across national borders.
The managing director is experienced in both areas and started at an early stage to shape these two strands.
The journey started with the Master´s Study Food- and Biotechnology at the University of Natural Resources and Life Sciences in Vienna, Austria. Because of personal interest and the vicinity of both countries Mr. Glaser learned the Czech language. He also participated in an exchange program at the University of Chemistry and Technology in Prague, Czech Republic.
Due to linguistic considerations the next logical station led him to Bulgaria via an academic exchange program. Since this time he improves the commands of the Bulgarian language and is able to read and write in Cyrillic. The knowledge of Slavonic languages is a matter of respect towards partners located in the CEE-region, but also helps to prevent potential misunderstandings in daily life.
Mr. Glaser held various positions with increasing responsibility in the pharmaceutical industry, i.e. as Lead of Regulatory Affairs AT & CEE at a marketing authorization holder based in Vienna. During his career in the drug regulatory affairs field, he soon developed further and took over additional quality management tasks in Austria and the CEE-region. In this role he focused on the implementation of the GDP-Guidelines in representation offices and conducted on-site audits at warehouses in the region. The knowledge gained by the postgradual course pharmaceutical quality management and his international experience enabled Mr. Glaser to do the job in a proper and efficient manner.
After completion of this valuable phase the next milestone on the journey was addressed: The move towards the establishment of an own business.
As preparation and for an optimal knowledge about the needs of potential clients Mr. Glaser passed the qualification examination for the wholesale of pharmaceutical products and chemicals. This exam is a prerequisite to run a warehouse for pharmaceutical products in Austria. Histros Ziviltechniker Ges.m.b.H. provides consultancy, but does not run a warehouse and does not act as broker.
Following the aforementioned motif of two strands, Mr. Glaser graduated from the master program Balkan studies. Especially the modules dealing with economics in the SEE-region are useful for the development of the company, which was established in the initial phase under the trade law.
A key milestone was achieved by passing the examination as chartered engineering consultant for food- and biotechnology. Subsequently, the company was transformed to "Histros Ziviltechniker Ges.m.b.H.". The fundamental expansion of the company´s authorizations mark the preliminary climax of the journey.
Mr. Glaser is delegated by the governor of Vienna to the board of examiners, which is responsible to conduct the examination for chartered engineering consultants for food- and biotechnology. In this role he assesses the candidates´ skills in the subjects "applicable legal and professional regulations" and "code of conduct".
Histros Ziviltechniker Ges.m.b.H. is designed to offer consultancy services in the field of regulatory affairs and to provide its clients a hub for the trade of certain FMCG-products.
The company and its managing director welcome clients and partners to continue the future journey together!
Educational Experience at a glance
✔ Examination as Chartered Engineering Consultant for Food- and Biotechnology
Chamber of Civil Engineers, Vienna, Austria (acc. to the Austrian Civil Technicians Act)
✔ Qualification Examination for the Wholesale of Pharmaceutical Products and Chemicals
Chamber of Commerce, Vienna, Austria, according to the Austrian Trade Law
(Histros Ziviltechniker Ges.m.b.H. does not act as wholesaler or broker)
✔ Postgradual Course Pharmaceutical Quality Management
University of Vienna, Austria
✔ Master´s Study Food- and Biotechnology
University of Natural Resources and Life Sciences, Vienna, Austria
✔ Master´s Study Balkan Studies
University of Vienna and the Institute for the Danube-region and the CEE-region, Vienna, Austria
incl. the update of the HACCP-concept at an industrial food manufacturer in Parvomay, Bulgaria (on-site)
✔ Exchange Program in the Czech Republic
University of Chemistry and Technology, Prague, Czech Republic
✔ Course Drug Regulatory Affairs
Middle European Organization for Regulatory Affairs, Vienna, Austria
✔ Trainings in Entrepreneurship and Apprentice Trainer
Chamber of Commerce, Vienna, Austria
✔ Exchange program in Bulgaria
Institute for the Danube-region and the CEE-region, Vienna, Austria
Trainings in Intercultural Communication and Course in Bulgarian language at the towns of Blagoevgrad and Varna
✔ Language Skills
German, English, Bulgarian, Czech
Professional Experience at a glance
✔ Establishment of companies acc. to the Trade Law and the Civil Technician Act
✔ Establishment and maintenance of QM-systems
✔ Lead and Co-Auditor at manufacturing sites and wholesalers in AT and the CEE-region (GMP and GDP)
✔ Support for the establishment of the supply chains for new markets and products in compliance with GxP
✔ Preparation and conduct of GxP trainings
✔ Regulatory support for the development of new markets
✔ Preparation and submission of full dossiers for new registrations in AT and CEE (EU- and non EU-territories)
✔ Life cycle management of already registered products
✔ Screening and upate of old dossiers
✔ Support of external laboratories regarding their equipment and procedures in order to analyze pharmaceutical products for compliance with the FPS (prior to the import/release to the market in non EU-territories)
Memberships
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Chamber of Civil Engineers, Vienna, Austria
✔ Association of Pharmaceutical Medicine (GPMed), Vienna, Austria
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Association of Austrian Food and Biotechnologists (VÖLBT), Vienna, Austria