Early-phase trials demand precision, speed and control. Every IMP must be produced, stored and administered to the required GMP standards, often under tight timelines and with minimal stability data.
Our GMP-licensed production facility in Antwerp, Belgium, is purpose-built for these challenges. Integrated directly within our state-of-the-art clinical pharmacology unit, it enables seamless coordination between production, pharmacy and clinical teams. We minimize cross-contamination, reduce logistical delays and enable same-day production and dosing.
We also operate in close collaboration with our UK-based CDMO, providing a full continuum of services, from formulation development to EU import, qualified person (QP) release, packaging, labeling and on-site administration. Whether you need full end-to-end support or a partner to manage QP release and production, we tailor our services to your study needs.
Discover the benefits of our IMP production facility
- Integrated GMP and clinical facilityOur production facility is located less than 100 meters from our clinical beds, enabling true bedside manufacturing and rapid response to adaptive trial protocols.
- Accelerated timelinesWe can import, release and dose within days – even overnight dose adjustments are feasible, thanks to in-house QPs and streamlined processes.
- Full compliance and traceabilityOur facility operates under GMP license 1289 IMP and is compliant with GDP standards for distribution across Europe.
- Expert oversightAll activities are managed by a dedicated team of experienced clinical trial pharmacists and QPs that are re-evaluated and certified every two years.
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
Facility and infrastructure
Cleanroom classification
Class B, C and D areas with active airlocks for contamination control and GMP compliance.
Environmental control
Continuous electronic monitoring of particles, humidity, temperature and pressure differentials for real-time GMP assurance.
Biosafety
Three Class A biosafety cabinets ensure product sterility and operator safety during critical operations.
Storage conditions
Facilities for 15–25°C, 2–8°C, -20°C, and -80°C conditions to accommodate a wide range of IMPs and materials.
Licenses
- GMP license 1289 IMP (2022)
- Import and distribution rights
- Controlled substances license (NL426)
- Anesthetics and psychotropic compounds (N°110049)
Your trusted partner in early-phase clinical research
As a trusted partner with over 40 years of experience in early-phase clinical research, we combine GMP expertise, regulatory intelligence and operational agility to deliver reliable, early-phase-ready production.
Our integrated Antwerp campus unites clinical pharmacology, laboratory and GMP manufacturing services, ensuring speed, safety and control. Supported by strong relationships with Belgian authorities (FAMHP/VAG), we bring flexibility and foresight to every project.
When you need to move fast without compromising compliance, we bring together the people, the facility and the mindset to make it happen.
