A small pharmaceutical company planned to reformulate an approved drug substance into a new name-brand product under 505(b)(2). PharmSupport:
- Devised regulatory and clinical strategy
- Created FDA briefing documents from pre-IND to pre-NDA
- Participated in meetings with FDA and with the development team
- Prepared and reviewed documents throughout the development process
- Prepared all of the clinical summary and overview sections of the NDA (in CTD format)
- Created a draft product label
- Assisted with review and compiling of nonclinical and manufacturing portions of the IND and NDA