Services · Secondary Packaging and Labelling of Investigational Medicinal Products
Coming soon to Lörrach, expected from the end of Q1 2027
We package and label your investigational medicinal products specific to the study, GMP-compliant under our own manufacturing authorisation pursuant to § 13 AMG, and supply the clinical trial sites according to your specifications. On request, with QP release from the same organisation.
Non-binding and confidential. Answer in one to two working days.
An approved trial whose investigational medication is not labelled to comply with regulations cannot start.
The question that matters
Yes. We carry out secondary packaging and labelling as a GMP-compliant manufacturing step under our manufacturing authorisation pursuant to § 13 AMG. Afterwards, our Qualified Person under § 14 AMG can release the same investigational medication, within the same organisation, for use in the clinical trial, with no handover to a further provider.
Every clinical trial requires investigational medication that is packaged and labelled specific to the study. We take on the secondary packaging and labelling of your investigational medicinal products as a GMP-compliant manufacturing step under our own manufacturing authorisation pursuant to § 13 AMG, and supply the clinical trial sites according to your specifications.
Labelling follows the Clinical Trial Regulation (EU) 536/2014 and the Detailed Commission Guideline C(2017) 8179 (Eudralex Volume 10). On request, our Qualified Person under § 14 AMG, within the same organisation, also handles release of the packaged investigational medication, one less handover and a single point of contact for both.
Process
4 Steps, a fixed contact person, no surprises.
Arrange an initial consultationYou describe the trial, the product, quantities and timeline. We tell you what packaging and labelling require.
We agree the packaging concept and label texts with you, in line with CTR 536/2014 and your specifications.
Execution as a GMP-compliant manufacturing step under our manufacturing authorisation pursuant to § 13 AMG, fully documented.
On request, our Qualified Person releases the investigational medication. We then supply the trial sites according to your specifications.
Typical initial situations
The trial is approved, the investigational medication manufactured. Study-specific packaging, labelling and supply to the sites are still missing.
You are developing the product but have no manufacturing authorisation of your own for packaging and labelling.
The trial start date is fixed. Packaging, labelling and release must fit reliably into the timeline.
An approved medicinal product is to be used as a comparator and must be repackaged and labelled specific to the study for this purpose.
Responsibility
You get the name, the legal role and the extension of the person who takes over your topic. Before the start of the contract, not afterwards, and not as a team, but as a person.
Business Development
Key areas
Training as a bank clerk, degree in pharmacy, licence to practise as a pharmacist, Master of Business Administration (MBA)
Investigational Medicinal Products and GCP
Key areas
Doctorate in clinical analytics, specialist pharmacist for clinical pharmacy
Founder and Managing Director
Key areas
Doctorate in analytical chemistry, degree in pharmaceutical sciences and chemistry
We clarify your questions in the initial consultation. Sascha Manthei takes the time for it.
Arrange an initial consultationSecondary packaging and labelling of investigational medicinal products are manufacturing steps. We carry them out under our own manufacturing authorisation pursuant to § 13 AMG, documented in a GMP-compliant manner.
The governing framework is the Clinical Trial Regulation (EU) 536/2014, supplemented by the Detailed Commission Guideline C(2017) 8179 (Eudralex Volume 10). We agree the label texts with you and document the labelling in a GMP-compliant manner.
Yes. Our Qualified Person under § 14 AMG can release the investigational medication for use in the clinical trial, within the same organisation, following packaging and labelling. Packaging, labelling and QP release then come from a single provider.
Yes. We supply the clinical trial sites according to your specifications and ensure GDP-compliant transport, together with experienced logistics partners where required.
Services that are often used together
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.
