About us · Since foundation · Three locations
Large service providers have the infrastructure, but you get changing contact persons. Individual consultants have the face, but no laboratory and no backup. A&O Pharma stands in between: own authorisation, own laboratory, and yet you know everyone who works on your topic.
Origin
A&O Pharma GmbH was founded because manufacturers, importers and biotech companies on the market usually find either size without proximity or proximity without infrastructure. We deliberately positioned ourselves in between.
As the holder of our own manufacturing authorisation according to § 13 AMG, we are responsible for the release by our Qualified Persons according to § 14 AMG as well as Regulatory Affairs and GMP-compliant processes. In addition, there is a GMP-certified, fully digitalised laboratory for highly sensitive LC-MS/MS analytics.
The three paths comparedAttitude
Behind every decision is a responsible person named with a legal role. You know who that is before the start of the contract.
Scientific accuracy and seamless documentation. What we deliver must not only be correct, it must also be demonstrable.
Clear scoping, short paths, binding schedules. No offer process taking weeks.
If a project does not belong to us, we say so in the initial consultation. This saves both sides time and both of us the wrong assignment.
Locations
Efringen-Kirchen on the Upper Rhine, Itzehoe in Schleswig-Holstein and Lörrach, which is currently being set up. The laboratory and the manufacturing authorisation belong to us, not a partner. Whoever calls us reaches all sites under the same number.
Head office Efringen-Kirchen
Management, Regulatory Affairs and consulting
A&O Pharma GmbHEfringen-Kirchen
The map loads only when you open it. Your browser then establishes a connection to Google.
Without Google, on OpenStreetMapItzehoe site
In-house GMP laboratory and manufacturing authorisation
A&O Pharma GmbHItzehoe
The map loads only when you open it. Your browser then establishes a connection to Google.
Without Google, on OpenStreetMapLörrach site
Being set up, expected to open at the end of Q1 2027
A&O Pharma GmbHLörrach
The map loads only when you open it. Your browser then establishes a connection to Google.
Without Google, on OpenStreetMapDirect line
One number, one mailbox
Team
Dr. Olaf Mundszinger
Qualified Person (QP) under § 14 AMG
Dr. Klaus-Peter Kreth
Head of Production (AMWHV)
Ute Hegener
Regulatory Affairs
Dr. Barbara Siebertz
Regulatory Affairs
Alexander Trautmann
GMP Consulting and Training
Leidy Fajardo
Risk Assessment and GMP Documentation
Dr. Kai Huwig
Qualified Person (QP) under § 14 AMG
Dr. Emmanuel Bey
Development Analytics
Tatjana Pazer
Quality Management and Sterile Manufacturing
Dr. Lenka Taylor
Investigational Medicinal Products and GCP
Sascha Manthei
Qualified Person (QP) under § 14 AMG
Dr. Thomas Lutz
Qualified Person (QP) under § 14 AMG
Call us or write three lines. You will reach someone directly who can assess your subject professionally.
As a member of the Life Science Nord cluster, we benefit from a strong, innovative network and work with other experts in the industry on forward-looking developments.
