A USA-based innovative pharmaceutical company approached Freyr for Regulatory support in filing pre-IND (Type B) meeting requests, type C meeting briefing materials, and promotional labeling advertising with the US FDA. Freyr analyzed the client’s existing processes to identify some of the significant constraints, such as tracking versions of frequently changed documents and replacing the same in eCTD, taking care of end-to-end publishing activities from study documents to final Electronic Submission Gateway (ESG) submission.
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