We will represent our clients during negotiations with the FDA regarding drug development strategy, navigating through the FDA’s regulatory submission, review, and approval processes (from Pre-IND, IND filing, various clinical development phases to NDA/BLA submissions). Our company provides expert knowledge in the fields of toxicology, DMPK, clinical pharmacology, clinical development, CMC, and CGMP compliance, all of which we contribute to FDA communications and drug applications. We offer our expertise for all types of meetings with the FDA, including but not limited to: pre-IND meetings, end of Phase1 meetings, end of Phase 2 meetings, pre-NDA/BLA meetings, and other regulatory meetings as needed, such as Type C, Type B, and Type A meetings. We help clients to prepare and submit Fast Track Designation, Breakthrough Therapy Designation and Orphan Drug Designation Requests.