Batch release · Marketing authorisation · Analytics
Small enough for maximum flexibility. Large enough for everything you need.
From authorisation to release to analytics in our own laboratory. From the application for a clinical trial to packaging/labelling to release. For each of these services you work with fixed contact persons and real infrastructure, not with changing teams from a large consulting firm and not with a sole practitioner without backup.
Authorisation, Release and responsibility
If your product is to be legally authorised and placed on the market or used in a clinical trial, we will take on the regulatory work and the qualitative responsibility for the 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 market in the EEA, and for anyone wanting to introduce an investigational medicinal product into a clinical trial.
Medicinal Product Release
QP release of investigational medicinal products (IMPs) under CTR 536/2014 and EU batch release of authorised medicinal products under Annex 16, under our own manufacturing authorisation pursuant to § 13 AMG.
Regulatory Affairs
Regulatory strategy, submission of marketing authorisation applications and clinical trial applications, Life Cycle Management. On request, we act as Interim Marketing Authorisation Holder.
Document Preparation
We take on the time-consuming preparation and maintenance of your GMP documents, from SOPs through Product Quality Reviews to risk assessments.
If internal resources or expertise are lacking
You have your processes, but need selective support. Analytics from our own laboratory, experienced minds for a limited period of time, or a second expert opinion. This affects established manufacturers just as much as growing companies: a short-term nitrosamine risk assessment, preparation for an official inspection, a vacancy in QM that has to be bridged. Instead of building up an entire department, you get exactly the capacity that is currently lacking, with a fixed contact person.
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 medication for your clinical trial and supply the clinical trial sites according to your specifications.
Analytical Services
Release testing and EU retesting, raw material testing under Ph. Eur. or an alternative monograph, cannabis analytics, biotechnological medicinal products, trace analysis by triple quadrupole LC-MS/MS, stability and microbiology.
Strategic 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 with regulatory inspections.
Operational QM/QA Support
We take on the ongoing QM/QA tasks that fall by the wayside in daily business: deviations, CAPA, change control, complaints, self-inspections and Product Quality Reviews.
Interim Management
Qualified Person (QP) under § 14 AMG, Graduated Plan Officer (Stufenplanbeauftragte) under § 63a AMG, Information Officer under § 74a AMG and further functions, on a fixed-term basis at your site.
One house. One contact person. An interdisciplinary team.
One house. No handovers.
A typical process for implementing a clinical trial or launching a medicinal product always includes several sub-processes, mostly with several service providers and the respective handovers. Valuable time and knowledge are lost with every handover. With us, a large part of the process can be realised from a single source, with the same contact persons, from the first page on paper to the released batch.
And if further internal expertise is required, these four dock at any point along the way:
Responsible
Every service has a name.
No changing contact persons, no impersonal enquiry system. You will find out before the start of the project who will take over your topic and which legal role this person holds.
View full team
Frequently asked questions about our services
We clarify your request in the initial consultation. Non-binding and concrete.
Does A&O Pharma offer all services combined?
Yes. You can commission batch release, regulatory affairs service and analytics or any of our other services individually or combined. Especially the combination of Qualified Person and own GMP laboratory is the reason why many clients come to us: fewer interfaces, one fixed contact person.
Can I start with a single service?
Of course. Many cooperations start with a specific occasion, for example a single batch release or analytics, and grow over time. You are not making a commitment beyond your current needs.
Does A&O Pharma work nationwide and internationally?
Yes. With the locations in Efringen-Kirchen, Lörrach and Itzehoe, we work with German as well as with EU clients and also support manufacturers outside the EU who are planning a market entry in the EEA.
How do I find out which service I need?
Fastest in an initial consultation. You describe your situation, we assess which service fits, and say honestly if we are not the right partner for your request. Often, however, we can help you with recommendations. Non-binding and concrete.
