IRAS Inc has extensive experience in preparation and/or review of regulatory submissions for biologic and drug products. Most of the consultants in this field have a high level of scientific expertise and also skills in project management in order to outline the most effective path to a successful regulatory submission.

•  Authoring/Review of regulatory submissions (IND, BLA, NDA, IMPD, CTA)
•  Preparation/Review of FDA briefing documents, meeting preparation (assist with appropriate list of questions) and post-meeting review
•  Planning and conducting of pre-IND, end of phase II, pre-BLA/NDA submission meetings
•  Ongoing application maintenance (amendments and supplements)
•  Request for Orphan Drug Designation
•  Request Orphan Grant
•  Request Fast track, break-through therapy
•  Application publishing and submission
•  Project management: Preclinical, Clinical, and CMC coordination and document management