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