##  [Successful BLA & MAA Submission for Chinese Pharma Company](/index%2ephp/case-studies/successful-bla-maa-submission-for-chinese-pharma-company) 

- [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)

 

 ![Successful BLA & MAA Submission for Chinese Pharma Company]()

A Chinese based pharmaceutical company approached Freyr for its BLA/ MAA business requirement to be submitted to the United States Food and Drug Administration (US FDA). Stringent timelines, multiple stakeholders were some of the challenges that the faced challenges.

Freyr’s support through thorough coordination in between Regulatory affairs, publishing and submission & medical writing team helped client successfully submit the required Regulatory documents to the Health Authority within time.



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