BEBAC - Consultancy Services for Bioequivalence and Bioavailability Studies

BEBAC is a private Austrian consultancy service company based in Vienna. BEBAC specialises in providing biostatistical services, contractor selection and supervision. We have wide experience with bioanalytics, pharmacokinetics, and biostatistics.

Our professional expertise (backed up by 28 years and more than 500 BA / BE studies) covers advisory activities, planning as well as analysis (analytics, biostatistics, PK / PD modelling) of Phase I clinical trials.

Bioequivalance and Bioavailbility study planning and evaluation

We are able to support our clients both in the planning stage and in the evaluation of studies, responding to deficiency letters, as well as preparation for regulatory hearings, placement and evaluation of CROs.

Each customer can expect to receive the particular types of services required to achieve his or her objectives as fast, efficiently, and cost-effectively as possible. Our view of ourselves is not that of an executing institution but that of a consulting partner making the customer’s objectives our own.

Regulatory framework of the drug development process

As regular lecturers at international conferences we have acquired close contacts to all parties involved in the drug development process. It is our strong belief that understanding the scientific principles behind the regulatory framework can support our clients better than following global guidelines as if carved out of stone.

Bioavailability and bioequivalence consultant - Helmut Schütz

Helmut Schütz studied Chemical Engineering in Vienna and is an independent consultant in the domain of bioavailability and bioequivalence studies. Mr Schütz has worked in the pharmaceutical industry and in an independent CRO, where he established a GLP certified laboratory information management system, holding senior management positions, most recently as the head of a biostatistical department.

Bioanalytics, pharmacokinetics, and biostatistics

He has extensive experience with bioanalytics, pharmacokinetics, and biostatistics. His professional experience covers 28 years and more than 500 BA/BE studies. For the past four years he has been working to set up BEBAC.

Helmut Schütz is a member of the Drug Information Association (DIA), the International Pharmaceutical Federation (FIP), the International Society for Clinical Biostatistics (ISCB), the International Biometric Society (IBS), the European Network for Business and Industrial Statistics (ENBIS), and the Austrian Pharmaceutical Association (ÖPhG).