Services

Topical Formulation Design and Development

• Pre-formulation studies (solubility, excipient compatibility, pH profiles)
• Prototype formulation design, development and optimization specific for the disease state
• Accelerated stability and packaging compatibility studies (pH, viscosity, conductivity, water content, microscopy)
• Process development and scale up
• IVRT (in vitro release testing)

Analytical Methods and Testing

• Method development for assay of API in drug product (HPLC, UPLC, LC/MS)
• Analytical method validation (phase-appropriate from GLP through Phase III/commercial stage)
• In process and finished product release testing
• Identification and quantitation of degradation products/related substances

Drug Product Manufacturing (gels, creams, ointments, solutions, sprays, pastes)

• Supplies for GLP studies (up to ~40 Kg)
• Supplies for GMP clinical studies (Phase I/II) with filling (tubes, vials, bottles, syringes)

Clinical Trial Material Services

• Clinical supplies packaging, labelling, and distribution (kit design, random code generation)
• Inventory management, returns accountability and destruction

Stability Studies

• ICH stability studies (temperature- and humidity-controlled storage, ICH conditions)
• Testing, tables, and reports
• Extrapolation for shelf-life determination