Generic Application Expertise

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.

Latest Resources

  • Blogs

    API Guidance Notes – Decode NPRA Malaysia Guidance

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  • White Papers

    Control of Nitrosamines in Drug Products Regulatory Considerations

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  • Past Webinars

    Competitive Generic Therapies (CGT) - FDA Requirements

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