Regulatory Affairs Team

The Regulatory Affairs Team at Masuu Global Solutions is responsible for ensuring compliance with regulatory standards across the Pharmaceuticals, Biopharmaceuticals, Healthcare, and Life Sciences industries. The team handles dossier writing in various formats (CTD, ACTD, eCTD, etc.), manages pre and post-approval submissions, provides strategic regulatory insights, and conducts dossier gap analysis. They also oversee regulatory labeling, eSubmission services, act as US Agents for FDA communications, and manage structured product labeling (SPL) services, including SPL XML conversion and drug listing.