A&O · Your full-service partner
QP batch certification for the EU under § 14 AMG, regulatory affairs, GMP consulting for your manufacturing, EU retesting in our own laboratory and fast labelling of your investigational medicinal products. Practical, reliable and backed by deep expertise.
A&O Pharma supports you in reaching your goals: with GMP-compliant manufacturing of your products, with batch release under § 14 AMG for companies without their own QP, and with regulatory questions. Do you need a reliable analytical laboratory for EU retesting? Or a flexible, fast solution for the secondary packaging and labelling of your investigational medicinal products? We offer well-considered, pragmatic solutions and practical advice, reliably and with in-depth expertise.
(Co-financed by the European Union / SH Schleswig-Holstein)
The project to fully digitalise the processes in our contract laboratory (LIMS implementation) is funded by the European Union and the State Government of Schleswig-Holstein.
Our focus is batch release and marketing authorisation for your medicinal products. Beyond that, we take care of everything that safeguards their route to market, all from one provider.
We verify GMP-compliant manufacturing and certify your batches for release in the EEA: investigational medicinal products under Regulation (EU) No 536/2014 and commercial medicinal products under EU GMP Annex 16, by our Qualified Person under § 14 AMG.
Learn moreFrom authorisation strategy and IMPD and MAA dossier compilation to submission and lifecycle management. On request, we act as interim marketing authorisation holder (iMAH) in the EU until you have chosen your commercial partner.
Learn moreGMP-compliant testing of your finished products, stability samples and raw materials in all common dosage forms, from solid and semi-solid to liquid. We develop and validate your analytical methods and perform specialised tests such as trace analysis (e.g. nitrosamines).
Learn moreBeyond the core services
Five further services along your product's path to the patient. Available individually or as a package, with the same contact person.
The gap
You need specialist expertise or a Qualified Person you can trust, plus the infrastructure behind them. The two rarely come together. Move the slider to see what is missing at either end.
Why A&O Pharma
We combine regulatory rigour with the speed of a specialised service provider, so your projects finish on time, stand up to regulatory scrutiny and stay within a predictable budget.
Qualified Persons, Stufenplanbeauftragte (German QPPVs) and management functions, available at short notice.
Clear scope, short decision paths and binding timelines, without agency-style waiting times.
Our own GMP-certified laboratory, including LC-MS/MS for nitrosamine and trace analysis.
Complete, GMP-compliant documentation of your data and processes that stands up to any regulatory inspection.
Since we began working together in 2020, A&O Pharma has impressed us as a GMP and GDP consultant in the pharmaceutical sector with its in-depth expertise, precision, flexibility and reliability.
We first contacted A&O Pharma with a cold enquiry. We were quickly impressed by the professional approach and the sound expertise of the Qualified Person (QP) who supports us on site. We have worked together on a basis of trust ever since and would recommend A&O Pharma without hesitation.
Team & Experts
Because of the way A&O is structured, you know everyone working on your project.
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 analysis, specialist pharmacist in pharmaceutical analysis
Regulatory Affairs
Degree in biology with a focus on molecular biology, plant metabolic physiology and enzyme chemistry, over 20 years of experience
Regulatory Affairs
Degree in biology with a doctorate, focus on molecular biology, biochemistry and botany, over 15 years of experience
+11Anonymised, but real. Typical projects, before and after we got involved.
View all case studiesAn authorised medicinal product was to serve as a comparator in a clinical trial. We oversaw its GMP-compliant sourcing and labelling and released the product.
Patients were to receive a medicinal product not yet authorised for their indication. We oversaw its GMP-compliant transfer into the compassionate use programme and released the product.
A multi-stage manufacturing process with many manual steps was to be automated in compliance with GMP. The phase 2a trial went ahead, and production time fell from months to a few hours.
Documents
All documents are available for direct download, no registration or form required.
A&O Pharma company presentation (PDF) with all our services in detail, from QP batch release and regulatory affairs to GMP consulting and analytical testing.
The whole company, in brief CertificateGMP certificate for the Efringen-Kirchen site, issued after an official inspection as evidence of Good Manufacturing Practice.
Part of QP Batch Release CertificateGMP certificate for the Itzehoe site, home to our GMP-certified laboratory, as evidence of Good Manufacturing Practice.
Part of QP Batch Release AuthorisationManufacturing and import authorisation (MIA) under §§ 13 and 72 AMG for the Efringen-Kirchen site.
Part of QP Batch Release AuthorisationManufacturing and import authorisation (MIA) under §§ 13 and 72 AMG for the Itzehoe site.
Part of QP Batch Release BrochureCompany flyer with an overview of our services and sites.
The whole company, in brief BrochureHow A&O Pharma acts as interim marketing authorisation holder (iMAH) in the EU until the authorisation is transferred to your partner.
Part of Regulatory AffairsNo. That is exactly what we are here for. You do not need to employ your own QP: our Qualified Person under § 14 AMG carries out batch certification and release for you.
Yes. We work with virtual pharma companies and biotechs on individual investigational medicinal products as well as with established manufacturers on ongoing projects.
With us, you have one dedicated, personal contact instead of changing teams: as personal as a freelancer, as well backed as a large organisation. We also hold a manufacturing authorisation under § 13 AMG at each site, in Lörrach expected from the end of the first quarter of 2027. Combined with our own GMP laboratory, this sets us apart from the vast majority of pharmaceutical consultancies.
Yes, we release investigational medicinal products and comparators for phase 1 to 3 trials under Regulation (EU) No 536/2014, as well as commercial medicinal products under Annex 16.
Yes. With our iMAH model, we apply for the marketing authorisation and act as interim marketing authorisation holder in the EU until you transfer it to your commercial partner.
Call us or write a few lines. You will reach someone who can assess your request with real expertise.
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.
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.
