RegRx Consulting, LLC Test or Service List : Drug Regulatory Affairs Services: Overall regulatory development strategy, Interactions with FDA and other regulatory authorities, Negotiating labeling with FDA, Maintaining INDs during development, Maintaining NDAs post approval, Review of advertising and promotional campaigns including new product launches, Review of press releases, Management of OIG/PhRMA Code compliance, Due diligence, US Agent services. Regulatory Applications: New Drug Applications (NDA), Investigational New Drug Applications (IND), Common Technical Documents (CTD), Clinical Trial Applications (CTA), Abbreviated New Drug Applications (ANDA), Orphan Drug Applications, Amendments, supplements, annual reports, safety reports, Registrations, drug listings, 505(b)2 applications