Breakthrough Therapy Designation →
- Our team has had great success in writing breakthrough therapy designations. Our depth of knowledge and experience in working with each review division informs the strategy of each application.
RMAT Designation →
- Our regulatory staff are well-versed in the unwritten rules of the FDA, and have had great success helping our client’s products achieve breakthrough status, among other designations
Priority Review Voucher →
- We are the largest submitter of priority review designation applications. We understand the challenge of these applications, and in particular, the level of scrutiny given to the epidemiology section.
IND Filings →
- We prepare, submit and maintain INDs. We work with many clients to streamline their strategy and work towards Orphan Designations, Pre-IND meetings, and IND submissions. Our team has a unique skill set that can generate successful submissions, in a rapid and expert manner.
- We stay with our clients from the lab to the market. We have strong experience in preparing marketing applications, as well as participating on the review of applications from inside the FDA.