Our CDMO Services
Pharmaceutical development according to your need
Pharmaceutical development of all common dosage forms.
Galenica delivers top-quality development services across a diverse range of formulation forms, including oral, pulmonary, nasal, and rectal applications.
We offer comprehensive services according to your pharmaceutical development needs, ensuring compliance with regulatory requirements and industry standards. Whether you are developing an innovative new compound or scaling up an existing formulation, Galenica provides the expertise, flexibility, and technical capabilities to meet your requirements.
Pharmaceutical development of all common dosage forms.
Pharmaceutical Development
• Comprehensive formulation & process development for oral, dermal, nasal, and pulmonary dosage forms, customized to meet the unique needs of your compound.
• Expertise in small molecules and peptides, ensuring broad support across diverse therapeutic areas.
• Preclinical development support, helping to refine formulations and select optimal excipients to improve stability and bioavailability.
• Development and optimization of immediate-release and modified-release formulations.
• Problem-solving expertise in overcoming bioavailability, solubility, and stability challenges, ensuring robust and scalable formulations.
• Regulatory CMC dossier support, including preparation data for IND, IMPD, NDA, and ANDA applications for seamless global regulatory approval.
Pharmaceutical development of all common dosage forms.
Analytical & Stability Testing
• Custom analytical method development, validation, and transfer to ensure reliable and reproducible product characterization.
• Comprehensive stability testing services in compliance with ICH guidelines, including forced degradation studies.
• Quality control (QC) testing for finished products to ensure consistency and compliance.
• Advanced analytical instrumentation, including HPLC/UPLC, LC-MS, NGI, FTIR, laser diffraction particle size analysis, and dissolution testing.
Pharmaceutical development of all common dosage forms.
Manufacturing & Scale-Up
• GMP-compliant manufacturing for clinical trial materials, ensuring consistent quality at every production stage.
• Flexible batch production for solids, liquids, and semi-solids, ranging from small-scale preclinical batches to medium-scale clinical supply production.
• High-potency compound handling with containment solutions and low RH (<20%) processing capabilities.
• Comprehensive secondary packaging and labeling solutions, including blinded clinical trial packaging.