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)
Packaging
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
Labeling
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
Services
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