IMP production services
Manufacturing and packaging
- Purchase and labelling of comparators
- manufacturing of IMPs (e.g., capsules and solutions for internal use)
- Primary and secondary packaging, including trial-specific labeling
Import and release
- EU import, batch certification 0and QP release of IMPs produced outside Europe
- Expertise in aseptically prepared sterile products and biologicals
Distribution
- GDP-compliant storage and distribution to clinical sites in Belgium and across Europe
QP consultancy
- QP batch release and documentation review
- Import licensing strategies and support
- Study-specific GMP production protocols
- Standard Operating Procedure (SOP) development and alignment with EU GMP guidance
