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Team · Legal roles · Three locations

Whoever works here takes responsibility by name.

At A&O Pharma, people with names bear the legal roles: Qualified Person according to § 14 AMG, Head of Quality Control, Graduated Plan Officer, Auditors and Analysts. You find out before the start of the contract who is taking over your project, and you can reach this person directly.

12
specialists in-house
5
statutory roles, named in person
8
services with dedicated persons responsible
3
Locations in Germany

The team

These people are working on your topic.

Not bought in, not on call. The legal roles according to the AMG are held personally by people from this company, and everyone here works at our own locations in Efringen-Kirchen and Itzehoe. You can reach each and every one directly.

Dr. Olaf Mundszinger Dr. Olaf Mundszinger Founder and Managing Director QP

Dr Olaf Mundszinger heads A&O Pharma and is Qualified Person (QP) under § 14 AMG. He studied pharmaceutical sciences and chemistry and holds a doctorate in analytica...

Education

Doctorate in analytical chemistry, degree in pharmaceutical sciences and chemistry

Key areas

  • Pharmaceutical quality control and quality assurance
  • Person responsible for narcotics
  • IMPD preparation
  • Pharmaceutical analytics
E-Mail +49 170 275 0459 LinkedIn Profil
Dr. Klaus-Peter Kreth Dr. Klaus-Peter Kreth Qualified Person (QP) under § 14 AMG

Dr Klaus-Peter Kreth is Qualified Person (QP) under § 14 AMG, heads Quality Control and is Head of Production under AMWHV. He holds a licence to practise as a pharma...

Education

Licence to practise as a pharmacist, doctorate in pharmaceutical analytics, specialist pharmacist for pharmaceutical analytics

Key areas

  • Quality management
  • Operational QA
  • Preparation, accompaniment and follow-up of regulatory inspections
  • Auditor
E-Mail +49 151 29 70 40 31 LinkedIn Profil
Ute Hegener Ute Hegener Regulatory Affairs

Ute Hegener works in Regulatory Affairs and brings over twenty years of experience in marketing authorisation. She studied biology with a focus on molecular biology,...

Education

Degree in biology with a focus on molecular biology, plant metabolic physiology and enzyme chemistry, over 20 years of experience

Key areas

  • Marketing authorisation
  • Strategic consulting
  • EU authorisation procedures
  • Life cycle maintenance
E-Mail +49 151 221 21229 LinkedIn Profil
Dr. Barbara Siebertz Dr. Barbara Siebertz Regulatory Affairs

Dr Barbara Siebertz works in Regulatory Affairs and brings over fifteen years of experience. She studied biology with a focus on molecular biology, biochemistry and...

Education

Degree in biology with a doctorate, focus on molecular biology, biochemistry and botany, over 15 years of experience

Key areas

  • Life cycle maintenance
  • Regulatory Affairs
  • Quality management
E-Mail +49 151 191 14724 LinkedIn Profil
Tatjana Pazer Tatjana Pazer Quality Management and Sterile Manufacturing

Tatjana Pazer is responsible for quality management and sterile manufacturing. She studied pharmacy, holds a licence to practise as a pharmacist and is a trained pha...

Education

Degree in pharmacy, licence to practise as a pharmacist, pharmaceutical technical assistant

Key areas

  • Sterile manufacturing and compounding
  • Computer system validation
  • Efficient quality management
  • Auditor
E-Mail LinkedIn Profil
Sascha Manthei Sascha Manthei Business Development QP

Sascha Manthei is responsible for Business Development at A&O Pharma and is Qualified Person (QP) under § 14 AMG and a pharmacist. He is responsible for pharmaceutic...

Education

Training as a bank clerk, degree in pharmacy, licence to practise as a pharmacist, Master of Business Administration (MBA)

Key areas

  • Qualified Person under § 14 AMG
  • Pharmaceutical quality management
  • GMP consulting
  • Auditor
E-Mail +49 160 965 545 44 Profil
Dr. Thomas Lutz Dr. Thomas Lutz Qualified Person (QP) and Head of Production QP

Dr Thomas Lutz is Qualified Person (QP) under § 14 AMG and Head of Production under AMWHV. The pharmacist, who holds a doctorate in pharmaceutical chemistry, is also...

Education

Degree in pharmacy, licence to practise as a pharmacist, doctorate in pharmaceutical chemistry

Key areas

  • Qualified Person under § 14 AMG
  • Head of Production under AMWHV
  • Responsible person for wholesale distribution of medicinal products under § 52a AMG
  • Graduated Plan Officer (Stufenplanbeauftragte) under § 19 Abs. 7 AMWHV
E-Mail +49 151 424 91235 Profil

Responsibility

Who is responsible for what.

You know who you are dealing with before the first meeting. Several names mean representation, not diffusion of responsibility.

Medicinal Product Release
Dr. Olaf Mundszinger Dr. Lenka Taylor Sascha Manthei Dr. Kai Huwig Dr. Thomas Lutz
Regulatory Affairs
Ute Hegener Dr. Barbara Siebertz Dr. Lenka Taylor Tatjana Pazer Dr. Emmanuel Bey Dr. Klaus-Peter Kreth
Document Preparation
Dr. Olaf Mundszinger Ute Hegener Dr. Barbara Siebertz Leidy Fajardo
Secondary Packaging and Labelling of Investigational Medicinal Products
Sascha Manthei Dr. Lenka Taylor Dr. Olaf Mundszinger
Analytical Services
Dr. Thomas Lutz Dr. Kai Huwig Dr. Emmanuel Bey
Strategic GxP Consulting & QA Support
Sascha Manthei Dr. Olaf Mundszinger Leidy Fajardo Dr. Emmanuel Bey Tatjana Pazer Dr. Klaus-Peter Kreth Alexander Trautmann Dr. Thomas Lutz
Operational QM/QA Support
Dr. Olaf Mundszinger Dr. Klaus-Peter Kreth Alexander Trautmann Leidy Fajardo Dr. Kai Huwig Tatjana Pazer Dr. Thomas Lutz
Interim Management
Dr. Olaf Mundszinger Dr. Klaus-Peter Kreth Alexander Trautmann Dr. Kai Huwig Tatjana Pazer Dr. Thomas Lutz

Locations

Three sites, one team.

Efringen-Kirchen on the Upper Rhine, Itzehoe in Schleswig-Holstein and Lörrach, which is currently being set up. Specialists work on site in Efringen-Kirchen and Itzehoe, and the laboratory and the manufacturing authorisation according to § 13 AMG belong to us.

Head office Efringen-Kirchen

Efringen-Kirchen

Am Sattel 17, 79588 Efringen-Kirchen, Germany

Itzehoe site

Itzehoe

Fraunhoferstraße 3, 25524 Itzehoe, Germany

Lörrach site

Lörrach

Marie-Curie-Straße 8, 79539 Lörrach, Germany

Direct line

+49 7628 95 03 119 o.mundszinger@aopharma.de

Let us talk about your project.

Call us or write three lines. You will reach someone directly who can assess your subject professionally.

Arrange an initial consultation +49 7628 95 03 119
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