Clinical Manufacturing


Blinding of IMP – e.g., over-encapsulation of a solid oral formulation

Batch release and certification by QP (QP release services)

Capsules Manufacturing (e.g. Placebo Capsules)






Primary Packaging of solid oral formulations

Packaging of all formulations and high potency drugs in cooperation with qualified partners

Secondary packaging of all formulations and packaging designs at our production sites

Provision of user-friendly packaging materials, controlled to fit quality specifications



Label design to enhance compliance of trial subjects, The client’s corporate identity can be integrated into the label

Labeling with the mono-/bi-/multi-lingual label (multi-language booklet label, wrap-around label, with or without documentation part/tear-off label)

Re-labeling in case of changes, (e.g., protocol amendments, new ‘use-by date’)

Compliance with 2001/20/EC, GMP and national drug laws (e.g., AMG), protocol specifications

Tear-off label to document subject compliance & drug accountability



Preparation of Emergency Envelops

Preparation of IMP section relevant to the IMP preparation

Preparation of international Master Label Forms

Selection of qualified packaging materials

Tailored packaging and labeling designs to meet study needs

Importation of IMP from extra-EU countries in agreement with EU requirements