Generic drug manufacturers, like any other pharmaceutical drug manufacturers, must prepare and compile the dossier required for registration of the generic drug in each country. Therefore, the drug companies adopt a globally harmonized format - Common Technical Dossier (CTD) - to avoid any duplication and for easier translation into different regional languages in a single application for registration of dossiers with multiple Regulatory Authorities.
Our CMC professionals helps in creation, review, and submission of dossiers in CTD/eCTD format for various Regulatory applications like, ANDA, ANDS, MAA, etc., as well as a gap analysis of source documents in line with current RTF/RTR expectations/GDUFA/CTD/ country-specific requirements.
Freyr through its generic application expertise over the years guides manufacturers with pre-submission activities, drug substance and drug product specifications, test methods, along with compilation, review, and submission of assessment reports and post-approval changes. Our lifecycle management services guide the client in Annual report/renewal submission strategy for successful product registrations across the globe.