Services · Secondary Packaging and Labelling of Investigational Medicinal Products
Coming soon to Lörrach, expected from the end of Q1 2027
We carry out trial-specific packaging and labelling of your investigational medicinal products, GMP-compliant and under our own manufacturing authorisation (§ 13 AMG), and supply the clinical trial sites according to your instructions. QP release from the same company is available on request.
No obligation, in confidence. We reply within one to two working days.
An approved trial cannot start if its investigational medicinal products are not labelled in compliance with the regulations.
The question that matters
Yes. We carry out secondary packaging and labelling as a GMP-compliant manufacturing step under our manufacturing authorisation (§ 13 AMG). Our Qualified Person under § 14 AMG can then certify the same IMPs in-house for use in the clinical trial, with no handover to another provider.
Every clinical trial needs investigational medicinal products that are packaged and labelled for that specific trial. We carry out secondary packaging and labelling of your IMPs as a GMP-compliant manufacturing step under our own manufacturing authorisation (§ 13 AMG) and supply the clinical trial sites according to your instructions.
Labelling follows the Clinical Trial Regulation (EU) 536/2014 and Commission guideline C(2017) 8179 (EudraLex Volume 10). On request, our Qualified Person under § 14 AMG also certifies the packaged IMPs in-house. That means one handover fewer and a single point of contact for both.
Process
4 steps, one dedicated contact, no surprises.
Book an initial consultationYou tell us about the trial, the product, quantities and timeline. We tell you what packaging and labelling will require.
We agree the packaging concept and label texts with you, in line with CTR 536/2014 and your specifications.
Carried out as a GMP-compliant manufacturing step under our manufacturing authorisation (§ 13 AMG), fully documented.
On request, our Qualified Person certifies the investigational medicinal products. We then supply the trial sites according to your instructions.
Typical starting points
The trial is approved and the investigational medicinal product has been manufactured. What is still missing is trial-specific packaging, labelling and supply to the sites.
You are developing the product but do not have your own manufacturing authorisation for packaging and labelling.
The trial start date is fixed. Packaging, labelling and release must fit reliably into the schedule.
An authorised medicinal product is to be used as a comparator and needs trial-specific repackaging and labelling.
Responsibility
You get the name, statutory role and direct phone number of the person handling your project before the contract starts, not afterwards. A named person, not a team.
Business Development
Key areas
Banking apprenticeship, degree in pharmacy, licence to practise as a pharmacist, Master of Business Administration (MBA)
Investigational Medicinal Products and GCP
Key areas
Doctorate in clinical analysis, specialist pharmacist in clinical pharmacy
Founder and Managing Director
Key areas
Doctorate in analytical chemistry, degree in pharmaceutical sciences and chemistry
Analytical Development
Key areas
Doctorate in pharmaceutical chemistry
Case studies
Anonymised projects from this service: starting point, approach and outcome.
We will answer your questions in an initial consultation. Sascha Manthei will take the time to go through them with you.
Book an initial consultationSecondary packaging and labelling of investigational medicinal products are manufacturing steps. We carry them out under our own manufacturing authorisation (§ 13 AMG), with GMP-compliant documentation.
The governing framework is the Clinical Trial Regulation (EU) 536/2014, supplemented by Commission guideline C(2017) 8179 (EudraLex Volume 10). We agree the label texts with you and document the labelling in line with GMP.
Yes. After packaging and labelling, our Qualified Person under § 14 AMG can certify the investigational medicinal products in-house for use in the clinical trial. Packaging, labelling and QP release then come from one provider.
Yes. We supply the clinical trial sites according to your instructions and ensure GDP-compliant transport, working with experienced logistics partners where needed.
Services that are often used together
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.
