A U.S. based, CRO Company approached Freyr to provide Regulatory submission pathway and support for preparation and submission of Type V DMF to the USFDA (Food and Drug Administration). Freyr had several challenges after acceptance of the project as the team had to deal with confidential data and had to educate client on the right Regulatory path for submission process.
Read through the case to the how Freyr helped the client in submission of Type V DMF to the USFDA?
Fill the form below to download the Case Study