Services

Our service profile


Below you will find an excerpt from our service profile

  • Procurement of medication, study material and medical devices
  • Labeling and secondary packaging for investigational medicinal products
  • Design of secondary packaging for clinical investigational medicinal products
  • Assembly of user-friendly center and patient boxes
  • Blinding of investigational medicinal products
  • Randomization of experimental and control groups (verum / placebo)
  • GMP compliant manufacturing and quality control
  • GMP compliant documentation
  • On demand service
  • Release according to §19 AMG by the qualified person
  • Storage and global shipping of IMP, study material and medical devices
  • Destruction of IMP / study material
  • Consultation and study coordination

Manufacturing


Labeling

The demands on clinical investigational medicinal products are getting higher and higher. Many information often needs to be accommodated in the smallest areas. Study materials such as small vials or syringes can be a challenge in the labeling process and subsequent processing. With our wealth of experience, we are well-equipped to meet these challenges and can therefore find the best possible solution for investigational medicinal products and study material flexibly and specifically.

In consultation with the sponsor or CRO we agree on:

  • Content (text) of the labels
  • Language options
  • Graphics and design
  • Printing of the labels
  • Printing of multi-page booklets and other elaborate labels in collaboration with partners


Labeling options

  • Simple and multi-lane labels
  • Multilingual booklet labels
  • Wide range of blank labels
  • Various seal labels
  • Blinding labels


When deciding which labels are right for your study, we are happy to help. The decision depends, for example, on which study design is being used and how the materials are to be repackaged.

In addition, we also offer label printing "on demand", so that you can stay as flexible as possible and also decide at short notice what quantities of IMP or study material you need


 
Relabeling

Another service we offer is the relabeling of already labeled study material / IMP. We can also guarantee the blinding of sensitive information with certain blinding labels.


Procurement of medication and medical devices

You are in need of medication or medical devices for your study or need to be able to supply your customers?

We can order medical products in larger quantities for you and if required, re-pack into smaller ones. We are in constant contact with manufacturers of medical devices and pharmaceutical companies so that we can supply you with the desired products in a timely manner.


Consulting

We would be pleased to advise you on the planning of your clinical study. 


Additional Services

  • Manufacturing license according to § 13 AMG
  • Import permit according to § 72 AMG
  • Wholesale license according to § 52a AMG
  • QP Services
    • Audits
    • Consulting
    • Product approval
  • Recall and destruction management
  • Organisation of returns