The Langford Research Institute
Focused the science of transdermal drug delivery, the Institute conducts formulation experiements, batch process design, clinical development and regulatory compliance due diligence.
The science of drug delivery has been advancing in the new millenium. Transdermal delivery is emerging as a critical tool in drug product desing and repurposing.
Langford Research has equipped itself with the tools and licenses necessary to provide incremental value in cGMP formulation, analytical method development and validation, product manufacture scale up, stability research and regulatory compliance.
The Institute also organizes and manages pre-clinical and clincal research for its developed formulations.
The Institute is licensed by the State of Florida as a cGMP pharmaceutical Manufacturer, by US DEA as a Researcher and Exporter, and by NIH as a research facility. The Institute maintains filings on FDA's Clinicaltrials.gov and conducts clinical research under current GCP standards. The Institute has sponsored research it proposed to the US FDA and the British MHRA and has be approved to conduct studies.
Institute principals are patented inventors, have represented the NIH and DOA as Research Ethics Oversight leaders in AAALAC-accredited institutions including the Scripps Research Institute, the Max Planck Florida Institute and Palm Beach Atlantic University.
The institute maintains an NIH registered Institutional Review Board or Ethics Committee which oversees Institute-sponsored research.
News & Events
Research Mechanisms and Data Analysis Techniques
The Institute has just successfully completed a Phase 0 Clinical study in healthy volunteers of a transdermally applied human insulin product.
The Institute will be applying for permission to begin a pivotal study of the transdermal Human Insuliin product in patients with Type 2 Diabetes Mellitus.
The Institute is also conducting stability studies as well as API vendor validation trials with a 3rd party provider in support of the ANDA.