BEBAC   Ing. Helmut Schütz

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News

EMA 2015-11-19 Q & A document
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EMA/FDA 2013-12-18 Inspections of BE Studies
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Guidance

EMA 2014-11-20 Guideline on MR dosage forms
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EMA 2014-10-23 Guideline on similar biological medicinal products
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FDA 2014-05-14 Draft Guidance: Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product
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FDA 2014-03-18 Draft Guidance: BA and BE Studies Submitted in NDAs or INDs
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FDA 2013-12-09 Draft Guidance on Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules
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FDA 2013-12-04 Draft Guidance on BE Studies with PK Endpoints for Drugs Submitted Under an ANDA
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EMA 2013-11-15 Draft product-specific guidance
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FDA 2013-09-13 Draft Guidance on Bioanalytical Method Validation
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Consultancy Services for Bioequivalence and Bioavailability Studies


BEBAC specializes in providing biostatistical services, contractor selection and supervision. We have wide experience with biostatistics, pharmacokinetics, and bioanalytics.
Our professional expertise covers advisory activities, planning and analysis of Phase I clinical trials.
We are able to support you in designing and evaluating studies, responding deficiency letters, as well as in the preparation for regulatory hearings, assessment and evaluation of CROs.


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 GALP-certified LIMS and held senior management positions, most recently as the head of a biostatistical department.
He has extensive experience with bioanalytics, pharmacokinetics, and biostatistics. His professional experience covers 36 years and more than 600 BA/BE studies.


Helmut Schütz is a member of the International Pharmaceutical Federation (FIP), the European Federation for Pharmaceutical Sciences (EUFEPS), the American Association of Pharmaceutical Scientists (AAPS), the International Biometric Society (IBS), the Austrian Pharmaceutical Association (ÖPhG), the European Network for Business and Industrial Statistics (ENBIS), and the Austrian Association of Consulting Engineers (FI).

Out of office dates

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