Ing. Helmut Schütz

directly to content (skip navigation)

• 
• Forum
• Guidelines
• News
• Lectures
• Contact
• Data Protection
• Sitemap

News

EMA 2018-08-03 Product-specific guidances
  ► read more…

ICH 2018-06-27 Draft Guideline on BCS-based bio­waivers
  ► read more…

FDA 2018-05-21 Guidance on Bioanalytical Method Validation
  ► read more…

FDA 2017-12-21 BCS-based Biowaivers
► read more…

FDA 2017-10-24 Drug-drug Interactions
  ► read more…

ICH 2016-10-07 Concept Papers on BCS- based bio­waivers and bio­analytical method validation
  ► read more…

FDA 2016-12-21 ANDA Submissions ― Refuse-to-Receive Standards
  ► read more…

HPFB 2016-04-18 BE Standards for HVDPs
  ► read more…

EMA 2015-11-19 Q & A document
  ► read more…

EMA 2014-11-20 Guideline on MR dosage forms
  ► read more…

EMA 2014-10-23 Guideline on similar biological medicinal products
  ► read more…

FDA 2014-05-14 Draft Guidance: Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product
  ► read more…

FDA 2014-03-18 Draft Guidance: BA and BE Studies Submitted in NDAs or INDs
  ► read more…

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 38 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).

 Short CV

Out of office dates

I am on sabbatical leave from November 15^th until February 1^st. These days, it will be difficult for me to read e-mail, and even more to answer.