BEBAC   Ing. Helmut Schütz

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EMA 2015-06-25 Q & A document
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EMA/FDA 2013-12-18 Inspec­tions of BE Studies
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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 guid­ances
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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 bioanalytics, pharmacokinetics, and biostatistics.
Our professional expertise covers advisory activities, planning and analysis of Phase I clinical trials.
We are able to support you in planning and evaluation, responding deficiency letters, as well as preparation for regulatory hearings, placement 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 GLP certified laboratory information management system, holding 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 35 years and more than 500 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 European Net­work for Business and Industrial Sta­tis­tics (ENBIS), the Aust­rian Pharma­ceu­ti­cal Asso­ciation (ÖPhG), and the Austri­an Association of Con­sulting Engineers (FI).

Out of office dates
4 months calendar

BEBAC – Consultancy Services for
Bioequivalence and Bioavailability Studies
Ing. Helmut Schütz

Neubaugasse 36/1/11
1070 Vienna, Austria
T: +43 (0)1 2311746
M: +43 (0)699 10792458

document date 2011-05-13 | last update 2015-12-02