Update the CTD Dossier and Successful Submission of ‘Type C’ Amendment

A U.S based client, one of the world’s fifth-largest consumer healthcare company, consulted Freyr to update their CTD dossier and to submit high quality amendment submissions for ‘Type C’ in regions like South Africa as well as SSA countries (Kenya, Tanzania, Uganda, Botswana, Ghana, Namibia, Nigeria, Zambia and Zimbabwe)​. There were several compliance gaps with tight deadlines.

Download the case to know how Freyr overcome the challenges and submitted the updated dossiers to the respective Regulatory authorities within the stipulated timeline.

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