AlphaCure works together with clients and provides strategic and technical advices to the clients for their success of a development program both scientifically and commercially. Provides document checklist for ANDA preparation.
Preparation of labeling artwork including Package insert label, Medication Guides, Patient Leaflets, Container Labels and Carton Labels
AlphaCure supports filing of documents throughout the product lifecycle of ANDA including amendments, supplements, annual reports and periodic adverse drug experience reports.
Provide submission services to regulatory authorities electronically using Axway Synchrony
Your Guide to a safe, effective, compliant product recall and Field alert reports.
Our cutting edge recall technologies document every step in the process to make regulatory reporting easier and ensure total compliance.