Collaboration
Royer Biomedical,Inc. currently has collaboration with several corporate partners (confidential), and selected institutions which are listed and briefly described below:
Corporate Collaborations:
Several (confidential)
Institutional Collaborations:
| Partner | Compounds | Therapeutic Targets | Status |
| Johns Hopkins NIH/ Brain Tumor Consortium |
R-Gel | Brain Tumors | Ongoing |
| Johns Hopkins Dept. of Anesthesiology | R-Gel with local anesthetic | Post-surgical pain | Ongoing |
| Ohio State University | Confidential | Vaccines | Confidential |
| Partner | Compounds | Therapeutic Targets | Status |
| Marion duPont Scott Medical Center (Univ. of MD/ VA Tech) |
MIII Cisplatin | Equine Tumors | Ongoing |
| R-Gel Antibiotic | Localized Infections | Ongoing |
Regulations
The FDA must approve Royer Biomedical, Inc. products. R-Gel Antibiotic is considered a device and we are pursuing 510 (k) approval. Other product candidates will be classified by FDA as a drug; however, in the case of R-Gel 5-FU a fast-track designation, which would result in an accelerated regulatory review, is possible. Importantly, Royer Biomedical, Inc. technologies utilize only previously approved ingredients, both active ingredients and inactive components. Royer Biomedical, Inc. will benefit from the 505b(2) classification, which means data of others may be cited in place of original studies. Veterinary products other than biologicals are regulated by the FDA/CVM (Center for Veterinary Medicine).