BioChem Labor für biologische und chemische Analytik GmbH is the service provider for its worldwide clients. Here you can find a selection of our services with which we can support you in your work. If you have any questions or concerns, please feel free to contact us at any time. We look forward to your enquiry.
Services provided by BioChem
In addition to the GMP certificate, BioChem also holds the Manufacturer’s Authorisation for
- human medicinal products and human investigational medicinal products acc. to § 13 AMG and
- veterinary medicinal products acc. to § 28 TAMG and (EU) 2019/6
BioChem’s manufacturing activities include microbiological, chemical/physical and biological quality control for medicinal products, raw and starting materials, active pharmaceutical ingredients and packaging materials.
All certificates are available for download in the Public Layout of the EudraGMDP database and on our homepage in the download section.
In addition to our extensive range of analyses, we offer a variety of services through our own QP (Qualified Person according to § 15 AMG), Ms Clarissa Kohn. Our QP service includes:
- Confirmation of quality control by QP
- Storage of retention samples acc. to § 18 AMWHV and Annex 19 GMP guideline
- Consulting on obtaining their own manufacturer’s authorisation
- Further consulting services, e.g., on GMP topics and regulatory requirements on request
In our brochure „Manufacturer’s Authorisation and QP service”, these services are summarised.
Qualified Person acc. to § 15 AMG
Deputy Head of Quality Assurance
Cross check expert acc. to § 65 AMG
Responsible Person for narcotic drugs and GÜG
Click here for more information on our services in the field of microbiological hygiene monitoring.
Click here for more information on our services in the field of stability studies (storage and analyses).
We will be pleased to arrange a transport service for the reliable and cost-effective shipping of your samples within a radius of approx. 300 km around Karlsruhe. The transport takes place under qualified conditions, e.g. 2-8 °C.
If you have any questions about the transport service, please contact our head office. We will be pleased to forward you to our contact persons.
The team of our sample and goods receipt is in service for the reception of samples at the following times:
|Monday to Thursday||…||8.00 a.m. – 4.00 p.m.|
|Friday||8.00 a.m. – 3.00 p.m.|
Please note that different times may apply around public holidays.
If analyses beyond our broad range of services are requested, qualified partner laboratories take over after consultation with our clients. This way, we can continue to offer all analyses from a single source as your service provider. This concerns e.g.
- Identification of impurities
- Special techniques such as XRPD, electron microscopy, NMR, LC-MS-MS, GC-MS or elemantary analysis