MedPharm supports stability programs for complex semisolid and liquid drug products across development and commercial stages. This integrated approach ensures stability studies are aligned with formulation strategy, product performance, and regulatory expectations.
Our stability services include:
MedPharm routinely designs and executes stability programs for a broad range of semisolid and liquid dosage forms.
Each stability program is tailored to address the specific risks associated with semisolid and liquid drug products, including phase behavior, rheological changes, preservative effectiveness, and container compatibility.
MedPharm performs the full range of stability studies required to support development and regulatory approval of semisolid and liquid drug products.
Stability protocols are developed based on the product’s formulation characteristics, development stage, and regulatory pathway.
MedPharm operates dedicated R&D and GMP stability storage facilities to support both development and registration-enabling stability programs.
ICH-qualified stability chambers maintain controlled storage conditions including:
• 25°C / 60% RH
• 30°C / 65% RH
• 40°C / 75% RH
Additional chambers can be configured to support region-specific stability zones or customized study requirements.
Specialized storage capabilities are also available for products requiring non-standard temperature conditions:
• Refrigerated storage (5°C)
• Frozen storage (-20°C)
• Ultra-low temperature storage (-80°C)
Stability programs are supported by experienced scientific teams who review stability data trends, evaluate degradation pathways, and contribute to shelf-life justification as part of an integrated development strategy.
Semisolid and liquid drug products present stability challenges that differ significantly from solid oral dosage forms. Stability programs must account for factors such as:
MedPharm designs stability strategies with these considerations in mind, ensuring stability programs accurately reflect real-world product performance.
Stability data generated at MedPharm supports global regulatory submissions, including:
MedPharm teams have extensive experience generating stability data suitable for regulatory review by agencies including the FDA, EMA, and MHRA, and for integration into Chemistry, Manufacturing, and Controls (CMC) documentation.
MedPharm combines stability testing capabilities with deep expertise in formulation development, analytical testing, and regulatory strategy for semisolid and liquid drug products.
This integrated approach allows sponsors to develop stability strategies that support successful progression from early development through clinical studies and commercial supply.
