A&O · Your partner with all-round service
Batch release according to § 14 AMG, Regulatory Affairs, consulting on GMP-compliant manufacturing, EU re-test in our own laboratory and rapid labelling of your test samples. Pragmatic, reliable and with comprehensive expertise.
A&O Pharma advises and supports you in achieving your goals, whether in the GMP-compliant manufacturing of your products, or in batch release according to § 14 AMG for companies without their own QP. Or with regulatory issues. Perhaps you need a reliable analytical laboratory to perform the EU Re-Test for you? Or a flexible solution for the fast secondary packaging/labelling of your test samples? We are at your side with well-thought-out, pragmatic solutions and with help and advice. Reliable and with comprehensive expertise.
(Co-financed by the European Union / SH Schleswig-Holstein)
The project for the complete digitalisation of laboratory processes (LIMS implementation) in our contract laboratory is funded by the European Union and the state government of Schleswig-Holstein.
The focus is on the release and authorisation of your medicinal products. Furthermore, we take care of everything that secures the way there, from a single source.
We verify GMP-compliant manufacturing and certify your batches for release in the EEA. For clinical investigational medicinal products (CTR 536/2014) and commercial medicinal products (Annex 16), by our Qualified Person according to § 14 AMG.
Learn moreFrom the authorisation strategy via IMP and MAA dossier compilation, the application for the authorisation procedure up to Life Cycle Management. Upon request, we act as Interim Marketing Authorisation Holder until you have chosen your commercial partner.
Learn moreGMP-compliant analytics of your finished products, stability samples and raw materials in all common dosage forms, from solid and semi-solid to liquid products. We develop and validate your analytical methods and carry out special tests such as trace analysis (e.g. nitrosamines).
Learn moreThe comprehensive service beyond
Five further fields secure the path of your medicinal product to the patient. Can be booked individually or as a package, with the same contact person.
The gap
You currently need special expertise or a Qualified Person you trust, and the infrastructure behind it. The two rarely exist together. Move the slider and see what is missing at each end.
Why A&O Pharma
We combine regulatory rigour with the speed of a specialised service provider so that your projects reach their goal on time, secure with authorities and with calculable effort.
Qualified Persons, Graduated Plan Officers and management functions, immediately deployable.
Clear scopings, short paths and binding schedules instead of agency waiting times.
Own GMP-certified laboratory, also with LC-MS/MS for nitrosamine and trace analysis.
Seamless, GMP-compliant documentation of your data and processes, resilient in every official inspection.
Since the beginning of our cooperation in 2020, A&O Pharma has impressed us as a GMP and GDP consultant in the pharmaceutical sector through deep expertise, precision, flexibility and reliability.
We approached A&O Pharma through cold acquisition. We were quickly impressed by the professional approach and the sound expertise of the Qualified Person (QP) who supports us on site. Since then we have worked together with great trust and would recommend A&O Pharma at any time.
Team & Experts
A&O's corporate structure has the advantage that you know everyone working on your topic.
Founder and Managing Director
Doctorate in analytical chemistry, degree in pharmaceutical sciences and chemistry
Qualified Person (QP) under § 14 AMG
Licence to practise as a pharmacist, doctorate in pharmaceutical analytics, specialist pharmacist for pharmaceutical analytics
Regulatory Affairs
Degree in biology with a focus on molecular biology, plant metabolic physiology and enzyme chemistry, over 20 years of experience
Qualified Person (QP) and Head of Quality Control
Degree and doctorate in chemistry, further education in pharmacy to attain expert knowledge under § 15 AMG
+8Anonymised, but real. This is what typical projects look like, before and after our deployment.
View all casesA sponsor without its own QP needed GMP oversight for manufacture in a non-EU country, the IMPD and release of the investigational medicinal product, all from a single source.
Active substance manufacture in a non-EU country, formulation development, analytics and QP release: a project combining almost all of our services.
Analytical method transfer to our laboratory, EU retesting, import and warehousing with a logistics partner. Launch planned for 2027.
Documents
All documents are available for direct download, without registration or form.
GMP certificate for the Efringen-Kirchen site, evidence of good manufacturing practice.
Belongs to Medicinal Product Release CertificateGMP certificate for the Itzehoe site, evidence of good manufacturing practice.
Belongs to Medicinal Product Release AuthorisationAuthorisation under § 13 AMG (MIA) for manufacturing and import at the Efringen-Kirchen site.
Belongs to Medicinal Product Release AuthorisationAuthorisation under § 13 AMG (MIA) for manufacturing and import at the Itzehoe site.
Belongs to Medicinal Product Release BrochureCompany flyer with a quick overview of services and sites at a glance.
The whole company, in brief BrochureA&O Pharma's Interim Marketing Authorisation Holder model explained concisely.
Belongs to Regulatory AffairsNo. That is exactly what we take care of. You do not have to employ your own QP, our Qualified Person according to § 14 AMG carries out the batch certification and release for you.
Yes. We work both with virtual pharmaceutical companies and biotechs on individual investigational products and with established manufacturers on ongoing projects.
You have a fixed, personal contact person with us instead of changing teams. Personal like a freelancer, secured like a large organisation. In addition, we hold a manufacturing authorisation according to § 13 AMG at each location, in Lörrach expected from the end of the first quarter of 2027. This, combined with our own GMP laboratory, distinguishes us from the vast majority of pharmaceutical consulting companies.
Yes, we release clinical investigational and comparator products for phase 1 to 3 trials according to CTR 536/2014, as well as commercial medicinal products according to Annex 16.
Yes. Via the iMAH model we apply for authorisation and act temporarily as the Marketing Authorisation Holder in the EU ourselves, until you transfer it to your commercial partner.
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.
