A US-based global technology and specialty materials company approached Freyr for Regulatory support for the Gap Analysis, Compilation, and Review of DMF to the United States Food and Drug Administration (US FDA). This included proper evaluation of gaps and their mitigation, updation of DMF based on the comments from stakeholders, and finally publishing of DMF in eCTD format by our Publishing and Submissions team and finally submitting them to the Health Authority, i.e., US FDA, via electronic submission gateway (ESG) within agreed timelines.
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