GMP Production Facility for Phase I
Health Inspired, Quality Driven.
About SGS Clinical Research
With over 40 years of experience as a mid-sized full-service contract research organization (CRO), we are a trusted partner in early-phase drug development. With our good manufacturing practices (GMP) production facility integrated into our clinical pharmacology unit in Belgium, we combine global standards with local regulatory intelligence and operational agility.
Our campus in Antwerp, Belgium, brings together a unique constellation of services – clinical pharmacology, laboratory services and GMP production – all in one state-of-the-art facility. This setup allows us to stay agile, compress timelines, reduce coordination overhead and respond quickly to your study needs. In combination with our contract development and manufacturing organization (CDMO) in the UK, we provide a seamless continuum of services:
from formulation development through to import, qualified person (QP) release, clinical packaging, dispensing and on-site administration. Already working with a CDMO? No problem. We pick up where they leave off, managing EU QP release of investigational medicinal product (IMP), production, packaging, labeling, dispensing and administration – all in one smooth, integrated process.
When you need to be sure, choose SGS.
We built this facility to close the loop – from formulation to
production to dosing. Fewer handovers. Fewer delays. More control. ” WIM VERRETH DIRECTOR, CLINICAL PHARMACOLOGY UNIT, SGS
GMP production services
Our GMP-licensed facility is purpose-built for early-phase clinical trials – designed for fast-moving timelines, small batches, on-site production, adaptive protocols and close coordination with clinical floor staff. Everything is handled on-site, within meters of our clinical beds, enabling small-scale, high-flexibility production with minimal stability data and full clinical supply support.
We offer Non-sterile manufacturing of IMPs, such as capsules and solutions for internal use Primary and secondary packaging, including trial-specific labeling EU import, batch certification and QP release of IMPs produced outside Europe – including aseptically prepared sterile products and biologicals (e.g. challenge agents, immunologicals) Distribution to clinical sites in Belgium and across Europe in full compliance with good distribution practice (GDP) standards
Our production facility holds GMP license 1289 IMP and meets all GDP requirements for distribution. Want sterile capabilities? Our brand-new Class B cleanroom is ready and currently undergoing accreditation – this service will be added soon.
Need to release and administer within 24 hours? That’s what this facility is built for. HEAD OF PRODUCTION FACILITY AND QP, SGS ELLEN VERHAVERT ”
Key infrastructure and technical specifications
FEATURE
DETAIL
WHY IT MATTERS
Enables a range of compounding activities under strict environmental control, ensuring GMP compliance for even the most sensitive products.
Cleanroom classification
Class B, C, D (with active airlocks)
Three preparation rooms (D, C, B), dispensing room, storage (NC)
Segregates activities to prevent contamination and maintain workflow efficiency.
Key rooms
+10 Pa differential between preparation areas and gowning rooms
Maintains cleanroom integrity and protects product quality by preventing cross-contamination.
Pressure gradients
Provides high-level containment for critical steps, ensuring both operator safety and product sterility.
Biosafety
Three Class A biosafety cabinets
Environmental controls
Particle monitoring, humidity, temperature, overpressure
Constant electronic monitoring with real-time oversight, reducing the risk of deviations and guarantees full GMP compliance.
Supports a wide range of IMPs, manufactured products, CMC materials, active pharmaceutical ingredients (API) and excipients.
Storage conditions 15–25°C, 2–8°C, -20°C, -80°C
Air-controlled pass-throughs, double-door fridge, large monitoring window
Enables efficient, contamination-free transfer of materials and visual QA/QP checks without breaching clean areas.
Key infrastructure
GMP 1289 IMP (2022), import and distribution rights, controlled substances (NL426), anesthetics and psychotropic compounds (N°110049)
Confirms regulatory approval for manufacturing, importing and distributing IMPs within the EU – ready to operate.
Licenses
Location advantage
Minimizes logistical delays, making same-day production and dosing possible – critical for products with minimal stability data.
<100m from trial beds – true bedside production
State-of-the-art facility
Our modern production facility is designed to minimize extraneous contamination, cross-contamination, errors and other hazards that could impact product quality. We ensure full GMP compliance and traceability at every stage. This setup allows us to manage a broad range of non-sterile manufacturing activities – from simple compounding to complex preparations that require precise environmental control.
QP consultancy Many early-phase sponsors struggle with European regulatory expectations. Our QP consultancy services offer practical, hands-on support to guide you through GMP requirements and import complexities.
We support you with: QP batch release and documentation review Import licensing strategies and support Standard operating procedure (SOP) development Study-specific GMP production protocols GMP alignment with EU guidance (including scenarios with minimal stability data)
Our proven track record and collaborative mindset have earned us the trust of the Belgian regulatory authority (FAMHP/FAGG), allowing us to offer flexibility without compromising compliance.
With fixed regulations, it is experience and foresight that create the best project-specific solutions. That is what we bring to every project. HEAD OF PRODUCTION FACILITY AND QP, SGS ELLEN VERHAVERT ”
Why SGS?
If you need a lean, responsive and reliable partner to get your drug to patients fast, we combine the people, the facility, and the mindset to make it happen.
Proximity production to patient – all on-site, no third-party coordination, no logistical delays Speed import, release and dose within days. Even overnight dose adjustments are possible Regulatory goodwill strong relationships with Belgian authorities (FAMHP/FAGG) foster pragmatic, constructive reviews
Designed for phase I small batches, minimal stability, adaptive protocols – we are built for it QP availability in-house expertise is rare – we have it covered Location in the heart of Europe – ideal for EU import and QP release of IMPs produced outside Europe
It is not just the cleanroom or the QPs – it is how we bring it all together: fast, coordinated, and always phase I-ready. ”
JELLE KLEIN MEDICAL DIRECTOR, SGS
Our pharmacy experts
Producing, storing and administering IMP drugs safely requires deep GMP expertise and proven experience.
Our GMP facility is staffed by a dedicated team of experienced clinical trial pharmacists and QPs, all highly trained in the unique demands of phase I trials. We operate with a team of ten full-time licensed pharmacists, all trained in GMP, regularly re-evaluated and re-certified every two years. Our operation is built for reliability, flexibility and precision – ensuring that your IMPs are handled by professionals who fully understand the critical nature of early-phase development. This in-house capacity allows us to maintain full control over the production cycle – eliminating dependency on external hospital pharmacies or third-party providers.
We blend strict GMP compliance with the practical know-how to handle tight timelines, unstable formulations and unexpected challenges. HEAD OF PRODUCTION FACILITY AND QP, SGS ELLEN VERHAVERT ”
Meet Ellen Verhavert
HEAD OF PRODUCTION FACILITY AND QP, SGS A hospital and industrial pharmacist with over 25 years of experience, Ellen has been with SGS for more than 10 years. She plays a central role in shaping production protocols, release pathways and operational workflows, with a strong focus on maintaining tight timelines and watertight processes. She is supported by a second QP to ensure business continuity and a dedicated team of more than ten clinical trial pharmacists.
Pharma Health Inspired, Quality Driven.
Contact us
clinicalresearch@sgs.com sgs.com/pharma sgs.com/linkedinpharma
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