We have solid experience in drafting IND, IMPD, NDA, MAA, DMF, EoPII Briefing Package, Comparability protocol. We will also QC the data going into submission and will provide guidance during the review process. We can perform the gap analysis, generate a list of possible questions, and formulate responses or generate the data to satisfy regulatory needs.
We can also participate in meetings with regulatory bodies to defend company’s position in from of FDA
