Main Offerings

If you are interested in exploring how Tioga Research might best help you advance your skin-applied product program, please contact us at
Minimally, we may be able to help you in your planning process.

Tioga Research delivers CRO services in the research and early development of skin-applied products, specializing in formulation innovation and skin permeation screening. With more than a decade of experience, we offer CRO services in support of topical drug products, transdermal drug products, prestige cosmetics, personal care products, and skin-applied medical device fields. Should we be tasked by a client with development of a new skin-applied drug product, from concept through to investigational new drug application (“IND”) filing, the process would typically entail (for a 505(b)(2) submission):

Concept assessment: Evaluation of commercial appeal (based on estimates of development timelines and costs, sales potential, and risks) and technical feasibility of prospective new topical or transdermal drug product.

Target product profile: Development of a detailed description of a prospective new drug product, in terms of indication, active pharmaceutical ingredient (“API”) nature and strength, formulation format, delivery requirements, development and regulatory paths, competitive products, differentiating benefits etc.

Preformulation & analytical: Virtual feasibility assessment; analytical method development and verification; assessments of ingredient compatibilities;, solubility measurements; gauging of competitive product performances.

Formulation innovation: Assessment & improvement of a current skin-applied formulation; formulation concept & library design; formulation discovery & refinement (with formulations innovation coupled closely with performance screening); spanning solutions, gels, creams, lotions, ointments, lacquers, foams, patches etc.

Skin permeation and Delivery measurements: Measurements of skin permeation and retention using traditional diffusion cells (Franz and other designs); employing human cadaver skin, porcine skin, nail, sebum, synthetic membranes etc.; from cream, gel, foam, solution, emulsion, lacquer, ointment, patch etc. formats; under finite or infinite dose conditions; permitted to work with Schedule II-V and Schedule I drug code 7360 (Cannabidiols etc.) controlled substances; and using analytics by HPLC, LC-MS, (LC-MS/MS with partner), liquid scintillation counting, ELISA etc.

High Throughput Experimentation: Tioga also provides skin delivery screening services using patented, patent pending and trade-secret high throughput experimentation (“HTE”) platforms including the award-winning INSIGHT™, and STORM™, FUROR™, TEMPEST™, and TORNADO™.

Formulation optimization: Adjustments to formulation composition and preparative procedures to optimize performance attributes; quality by design experiments and assessment of formulation robustness; excipient sourcing; platinum-standard skin permeation & retention measurements.

Measurements of product attributes, such as esthetics: Physical property measurements; subjective assessment of esthetics by panels.

Patent support: Formulation engineering to enable freedom to operate by circumventing protected compositions; patenting strategy input; support in application drafting; accumulation of experimental data to support claims (such as more comprehensive examples and claims support using proprietary high throughput experiment (“HTE”) platforms).

Stability: Informal and formal assessments of formulation stability under normal (25°C) and accelerated (40°C) conditons, in qualified stability chambers.