Infill team has extensive experience in preparing, reviewing, submitting INDs, ANDAs, MAAs in CTD / eCTD formats and getting approval of drug products from various Health Authorities (US FDA, EU and others). The team is also well experienced in the preparation, review, submission and approval of DMFs (CTD/eCTD formats) from Health Authorities (US FDA, EDQM, EU and others) for global markets.
The team has prepared meeting requests, packages and had face-to-face meetings (Pre-ANDA, Pre-IND, EOP, and GMP) with US FDA. Also had multiple telephonic meetings with various Health Authorities (US FDA, EMA, and MHRA).