##  [Supported Generic Manufacturer in ANDA Dossier in CTD format for USFDA](/index%2ephp/case-studies/supported-generic-manufacturer-in-anda-dossier-in-ctd-format-for-usfda) 

- [Medicinal Products](/index%2ephp/case-studies-main-categories/medicinal-products)
- [Medical Writing](/index%2ephp/case-studies-main-categories/medical-writing)





[US FDA](/index%2ephp/case-studies-heath-authority/us-fda)

 

 ![Supported Generic Manufacturer in ANDA Dossier in CTD format for USFDA]()

A US-based generic medicinal product manufacturer approached Freyr for Regulatory support in submitting a ANDA dossier for one of its generic product to the United States Food and Drug Administration (US FDA).

The client faced challenges in streamlining the process, meeting stringent timelines, and last minutes reviews and modifications. Freyr’s support to the client from the initial scope analysis process until the module-level review and compilation. With several other clients benefits the project was successfully completed.



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