Clinical Secondary Packaging & Labelling

Validated Label Design & Print

Clinical secondary packaging is a vital step in the supply chain and involves the label design, language translations, and application of labels to a wide range of package types including bottles, blister cards, vials, syringes, pouches, tubes, inhalers, and other devices.

This results in the creation of patient kits which are released and distributed via our global storage and distribution network to ensure they arrive on time to treat patients participating in clinical trials across the globe.

Label Design, Randomisation, & Language Translations

In-house label design and printing
Single, multi-panel & booklet labels
Blinding

Randomisation list sourcing
Label text translations
Special condition labels to maintain adhesion at different temperature ranges

Just in Time (JIT) Labelling

Just in Time (JIT) protocols can be created to perform certain modifications to clinical supplies.
For example:

Label application to QP released patient kits

Addition of a label displaying protocol or study number prior to dispatch to clinical sites

Controlled Room Temperature & Cold Chain Packaging & Labelling

Customised assembly, packaging, & labelling of patient kits

Environmentally controlled rooms/storage facilities for medicinal products with limited stability
- Ambient (+15°C to +25°C)
- Refrigerated (+2°C to +8°C)
- Frozen (-25°C to -15°C)

Light Sensitive Product Packaging

Low/Variable illuminance: 400 – 1,000 lux

Low wavelength: Amber or UV filters

QP Services

We will assign a Qualified Person (QP) to guide you on the documentation required for QP release.

If necessary, the QP can issue a declaration for a Clinical Trial Application (CTA) to cover the importation of a medicinal product into the EU.

Once the patient kits have been produced, the QP will then perform the mandatory release and certification of the kits so that they can be distributed seamlessly to clinical sites within EU countries.

Custom Solutions

At BAP Pharma, we develop solutions that are customized to your needs, leveraging our broad suite of capabilities that include clinical secondary packaging, validated label design & print, kit assembly, special condition packaging and warehousing, and our global distribution network. In combination with our extensive project management experience, this means you get the global solution for success.