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About us · Since our founding · Three sites

The gap between large service providers and independent consultants.

Large service providers have the infrastructure, but your contacts keep changing. Independent consultants offer a familiar face, but no laboratory and no backup. A&O Pharma sits in between: our own authorisation, our own laboratory, and you still know everyone working on your project.

8
service areas
§ 13 AMG
our own manufacturing authorisation
§ 14 AMWHV
GMP-compliant quality control
3
Locations in Germany

Background

Why we exist.

A&O Pharma GmbH was founded because manufacturers, importers and biotech companies usually have to choose between scale without personal contact and personal contact without infrastructure. We deliberately positioned ourselves in between.

As holder of our own manufacturing authorisation under § 13 AMG, we take responsibility for batch release by our Qualified Persons under § 14 AMG, as well as for regulatory affairs and GMP-compliant processes. We also run a GMP-certified, fully digitalised laboratory for highly sensitive LC-MS/MS analysis.

The three paths compared
A&O Pharma The independent consultant The large service provider
  • Our own manufacturing and import authorisation (MIA) under § 13 AMG
  • In-house GMP-certified laboratory, fully digitalised
  • Named Qualified Persons
  • In-house cover, at three sites

Principles

What we stand for.

Named responsibility

Every decision is backed by a named person in a statutory role. You know who that is before the contract starts.

Precision that stands up to inspection

Scientific accuracy and complete documentation. What we deliver must not only be correct, it must also be verifiable.

Speed through clear agreements

Clear scoping, short decision paths, binding timelines. No quotation process that drags on for weeks.

Honest, even when the answer is no

If a project is not right for us, we say so in the initial consultation. That saves both sides time and spares us both the wrong engagement.

Locations

Three sites, one standard.

Efringen-Kirchen on the Upper Rhine, Itzehoe in Schleswig-Holstein, and Lörrach, which is currently being set up. The laboratory and the manufacturing authorisation are our own, not a partner's. One phone number reaches all sites.

Head office Efringen-Kirchen

Efringen-Kirchen

Management, regulatory affairs and consulting

A&O Pharma GmbH
Am Sattel 17
79588 Efringen-Kirchen
  • Registered office
  • Regulatory Affairs
  • GMP and GxP consulting
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Efringen-Kirchen

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Itzehoe site

Itzehoe

In-house GMP laboratory and manufacturing authorisation

A&O Pharma GmbH
c/o IZET Innovationszentrum
Fraunhoferstraße 3
25524 Itzehoe
  • GMP-certified laboratory
  • Manufacturing authorisation under § 13 AMG
  • Batch release and analytical testing
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Itzehoe

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Lörrach site

Lörrach

Being set up, expected to open at the end of Q1 2027

A&O Pharma GmbH
Marie-Curie-Straße 8
79539 Lörrach
  • Packaging and labelling
  • Storage and distribution
  • Batch release under our own manufacturing authorisation (§ 13 AMG)
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Lörrach

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Team

The people behind A&O Pharma.

All experts

Tell us about your project.

Call us or write a few lines. You will reach someone who can assess your request with real expertise.

Life Science Nord

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.

Scientist.com Registered Supplier

As a registered supplier on Scientist.com, we can also be reached through this platform: companies registered there can send their project requests directly to us.