IMP Manufacturing

GMP-compliant manufacturing of investigational medicinal products (IMPs) is carried out in a fully equipped 1,340 m² facility designed for small-scale production to meet clinical trial needs, including Phase I, Phase II, pilot, and bioequivalence (BE) studies. Services cover the full process from development to quality release, ensuring consistent product quality, regulatory compliance, and reliable clinical supply.

Formulation development

Capabilities

GMP manufacturing – Small-batch production under strict GMP conditions, ensuring product consistency and compliance
Quality release – Regulatory-compliant procedures verifying that clinical trial materials meet all analytical and quality criteria
Stability studies – Conducted in accordance with ICH guidelines to confirm product stability throughout the development period
Modern quality management – A robust Quality Management System ensuring traceability, risk management, and compliance at every stage

Non-Sterile Dosage Forms – Advanced Development and GMP Manufacturing

Manufacturing capabilities include a wide range of non-sterile dosage forms for clinical trials and specialty production. Processes are designed for formulation flexibility, precise dosing, and consistent therapeutic performance, with all activities conducted under current GMP requirements.

Hard capsules – Filled with powders, granules, or pellets for various release profiles and formulation needs
Granules – Developed for oral suspension or direct administration with controlled particle size and dissolution rates
Powders – Blended and filled for immediate or modified release with optimised bioavailability
Pellets – Multiparticulate controlled- or sustained-release systems for consistent therapeutic delivery
Oral dispersible films – Rapidly dissolving films for systemic absorption, improving patient compliance, including paediatric and geriatric use
Tablets (uncoated & coated) – Immediate or modified-release tablets, including film-coated versions for improved stability and adherence
Transdermal systems – Patches enabling systemic drug delivery with precise dosing control
Solutions as intermediates – High-quality liquid intermediates for integration into complex formulations

All dosage forms and manufacturing processes follow current GMP requirements and are supported by a comprehensive Quality Management System to ensure reproducibility, compliance, and product quality. From initial production to final clinical release, each step is documented and controlled to meet regulatory expectations and support reliable progression of clinical development programmes.