Services

Packaging and Labeling

Secondary packaging of investigational medical products

One of our expertise is the secondary packaging of clinical investigational products. In accordance with GMP guidelines, we can customize the packaging as per your request.



Labeling

We understand the complexities when deciding which label would be the most suitable for your project. The requirements on clinical investigational medical products are getting stricter in the US and Europe. We are proud to bring our expertise for these challenges to find the best possible solution for your investigational medicinal products.

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 it comes to deciding which labels are right for your study, we are happy to help. The decision depends on which study design is available and how the materials will 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 undertake is the relabeling of already labeled study material / IMP. We can also guarantee the blinding of sensitive information with certain blinding labels.

Storage

Storage of IMP and medical devices

  • Storage of IMP at controlled temperatures: room temperature: 15 to 25 ° C
  • Cooling at 2 to 8 °C
  • Cooling at low temperatures: -15 to -25 ° C and -140 to 196 ° C
  • Sponsor-specific storage
  • Quarantine storage
  • Long-term storage
  • Storage of return samples
  • Storage of stem cells
  • Storage of serum samples (Frozen sample management)

Guarantee of safe storage through strict surveillance measures:

  • 24-hour alarm monitoring
  • Temperature monitoring with alarm system
  • Emergency generators
  • Fire alarm system
  • Alarm system and motion detector

Shipping

Shipping of clinical investigational medical products
  • Worldwide shipping of IMP and study materials
  • Shipments at the following temperatures:
    • -190 °C
    • -80 °C
    • -20 °C
    • 2-8 °C
    • 15-25 °C
  • Direct contact with the courier before, during and after shipping
  • Creation of all shipping documents (customs papers, import licenses, etc.) in cooperation with the customer
  • Evaluation of the temperature records of the transport
  • Transport insurance

Additional Services

Shipping of clinical investigational medical products
  • Worldwide shipping of IMP and study materials
  • Shipments at the following temperatures:
    • -190 °C
    • -80 °C
    • -20 °C
    • 2-8 °C
    • 15-25 °C
  • Direct contact with the courier before, during and after shipping
  • Creation of all shipping documents (customs papers, import licenses, etc.) in cooperation with the customer
  • Evaluation of the temperature records of the transport
  • Transport insurance


Procurement of medication and medical products

You need medication or medical devices for your study 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 gladly advise you on the planning of your clinical study.

Other core 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
  • 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