We help our clients advance their topical and transdermal drug programs all the way from product concept assessment through to first regulatory filing, or with one or more stages in between. Our parent company, Encube Ethicals, is a global leader in topical contract manufacturing services, operating the world’s largest single-site manufacturing site for such products. Together, Tioga Research and Encube Ethicals can support our clients from early formulation product innovation through to full-scale commercial manufacturing.
Clients regularly seek the support of Tioga Research for one or more of:
• Analytical method development & verification
• Pre-formulation (solubilities, compatibilities etc.)
• Formulation re-engineering (for delivery improvements and freedom to operate)
• Formulation innovation (for optimal performance & patentability)
• Skin delivery & permeation screening
• Broad-based screening of formulations using proprietary high throughput experimentation platforms (such as INSIGHT™, STORM™, TORNADO™ and SPLASH™)
• in vitro release testing (“IVRT”) & in vitro permeation testing (“IVPT”) under GLP conditions for release and bioequivalence support
• Formulation optimization
• Stability assessments
• Product esthetics assessment (sensory panels)
• Skin safety studies (employing third-party CRO)
• Patent application support
• Technology transfer
#TiogaResearch helps progress client programs intended for the spectrum of regulatory paths: #topical505b1, #transdermal505b1, #topical505b2, #transdermal505b2, 505(j) (or ANDA), 510(k) and PMA. We are particularly adept at creating high-performing formulations that have a robust basis for composition of matter patentability.
#TiogaResearch supports personal care and skin care companies by creating and deploying new measurement platforms, by information mining and text data aggregation, by innovating excipient packages, and by completing measurements of skin deposition, delivery and permeation.