Batch release · Marketing authorisation · Analytical testing
Small enough for maximum flexibility. Large enough for everything you need.
From marketing authorisation and batch release to testing in our own laboratory. From the clinical trial application and packaging/labelling to release. For each service you work with dedicated contacts and real infrastructure: not a rotating team from a large consultancy, and not a lone consultant with no backup.
Marketing authorisation, Release and responsibility
If your product needs to be authorised and placed on the market in full compliance with the law, or used in a clinical trial, we take on the regulatory work and the quality responsibility for batch release. This is typical for pharmaceutical companies without their own regulatory affairs department and Qualified Person, for manufacturers outside the EU planning to enter the EEA market, and for anyone bringing an investigational medicinal product into a clinical trial.
QP Batch Release
QP certification of investigational medicinal products (IMPs) under CTR 536/2014 and EU batch release of authorised medicinal products under Annex 16, under our own manufacturing and import authorisation (§§ 13 and 72 AMG).
Regulatory Affairs
Regulatory strategy, marketing authorisation and clinical trial applications, and lifecycle management. On request, we act as interim marketing authorisation holder (iMAH) in the EU.
GMP Document Preparation
We take on the time-consuming preparation and maintenance of your GMP documents, from SOPs and Product Quality Reviews to risk assessments.
When you lack in-house capacity or expertise
You have your processes but need targeted support: analytical testing in our own laboratory, experienced people for a limited period, or a second expert opinion. This applies to established manufacturers as much as to growing companies: a nitrosamine risk assessment at short notice, preparation for a regulatory inspection, a QM vacancy that needs to be bridged. Instead of building an entire department, you bring in exactly the capacity you are missing, with one dedicated contact.
Coming soon to Lörrach, expected from the end of Q1 2027
Secondary Packaging and Labelling of Investigational Medicinal Products
We package and label the investigational medicinal products (IMPs) for your clinical trial and supply the trial sites according to your instructions.
Analytical Services
Release testing and EU retesting, raw material testing to Ph. Eur. or an alternative monograph, testing of medicinal cannabis and biotechnological products, trace analysis by triple quadrupole LC-MS/MS, stability testing and microbiology.
GMP and GxP Consulting & QA Support
Analytical method validation, qualification of equipment and premises from DQ to PQ, manufacturing transfers, process and cleaning validation, GxP audits and support during regulatory inspections.
Operational QA Support
We take on the routine QA tasks that get left behind in day-to-day business: deviations, CAPA, change control, complaints, self-inspections and Product Quality Reviews (PQRs).
Interim Management
Qualified Person (QP) under § 14 AMG, Stufenplanbeauftragter (German QPPV) under § 63a AMG, Information Officer under § 74a AMG and other roles, for a fixed term at your site.
One company. One point of contact. An interdisciplinary team.
One provider. No handovers.
A typical clinical trial or product launch always involves several sub-processes, usually with several service providers and a handover between each of them. Valuable time and knowledge are lost with every handover. With us, much of the process stays with one provider and the same contacts, from the first page of the dossier to the released batch.
And if you need additional expertise, these four services can join at any stage:
Responsible
Every service has a named person behind it.
No rotating contacts, no anonymous ticketing system. Before the project starts, you know who will handle it and which statutory role that person holds.
View full team
Frequently asked questions about our services
We will discuss your request in an initial consultation. No obligation, and to the point.
Does A&O Pharma offer all services as a package?
Yes. You can commission batch release, regulatory affairs or analytical testing, or any of our other services, individually or in combination. The combination of a Qualified Person and our own GMP laboratory in particular is why many clients come to us: fewer interfaces and one dedicated contact.
Can I start with a single service?
Of course. Many working relationships start with a specific need, such as a single batch release or an analytical test, and grow over time. You do not commit to anything beyond your current needs.
Does A&O Pharma work across Germany and internationally?
Yes. From our sites in Efringen-Kirchen, Lörrach and Itzehoe, we work with clients in Germany and across the EU, and we also support manufacturers outside the EU that are planning to enter the EEA market.
How do I find out which service I need?
The quickest way is an initial consultation. You describe your situation, we assess which service fits, and we tell you honestly if we are not the right partner for your request. Even then, we can often recommend someone who can help. No obligation, and to the point.
