REGULATORY & DOSSIER SUPPORT
Registration-Ready Pharmaceutical Supply
We support international partners with the product documentation and regulatory coordination required for pharmaceutical registration and market entry, using dossiers and documentation provided by our manufacturing partners.
Documentation Support May Include
Product Dossiers
CTD / eCTD where applicable
Manufacturing Documents
Manufacturing documentation & GMP certificates
Certificate of Pharmaceutical Product
Provided where applicable
Certificate of Analysis
Product quality and analytical documentation
Stability Data & Specifications
Product specifications and available stability documentation
Packaging & Artwork Support
Packaging information and regulatory artwork coordination
Pharmacovigilance & Regulatory Declarations
Supporting documentation according to applicable product and market requirements
Built for International Market Entry
Our regulatory support process helps partners organize the documentation required for product evaluation, registration and subsequent commercial supply.
Documentation coordination
Regulatory review support
Commercial supply coordination