Our Services
Orphan Drug Designation
We prepare orphan drug designation applications for the Food and Drug Administration and European Medicines Agency. Earning orphan drug designation entitles the drug sponsor to various financial benefits.
Regulatory Affairs Expertise​
We can assess your progress in the drug development process and deliver a strong regulatory plan to help you bring your orphan drug to market and capitalize on the regulatory benefits of orphan designation.
FDA Meetings
We'll help you get a meeting with the FDA to gain insight into their thoughts into your drug and the drug development process. We'll ensure that you get the most out of your FDA meeting to get your drug to market!
Investigational New Drug Applications​
Before first-in-human clinical trials, the sponsor must file an IND with the FDA showing that the drug is safe. After a pre-IND meeting with the FDA, we'll help prepare your IND for submission.
Additional Regulatory Services
We help you prepare and submit applications for expedited programs such as accelerated approval, breakthrough therapy, fast track, and priority review as well as additional programs such as Qualified Infectious Disease Program designation and the 505(b)(2) regulatory pathway.
Medical Communications
​We can help you with grant writing, producing educational content for a wide variety of audiences, and more. While our primary focus is rare disease, we can assist with communications related to other disease states as well.