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
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