Scientific & Regulatory Affairs Consultation

Frontage offers comprehensive in vitro and in vivo testing services, from preclinical formulation assessments to early phase human studies, for topical products.

An extensive menu of in vitro studies helps you:

  • Develop and select the optimal formulation
  • Assess the effect of penetration enhancers/modifiers on percutaneous absorption
  • Develop and validate novel analytical and sample processing methods for optimized sensitivity and selectivity
  • Develop, validate, and conduct in vitro release test (IVRT) assays for FDA SUPAC-SS submissions
  • Provide compliance for GLP studies and analytical method validations

Our IVRT method development and validation services for topical dosage forms such as ointments, creams, lotions, gels and liquid include:

  • Generic (e.g., RLDs) versus innovator drugs comparison
  • Pre- and post-change formulations comparison
  • Quality control/lot release, lot-to-lot variability
  • Formulation optimization  
  • Analytical method development and validation

Just tell us what your needs are, and discover how well we can accommodate them.