Industry: Healthcare Topic: Regulatory Tone: Formal/Professional Outline & Structure: ICH eCTD Structure Extra notes: We are currently in the beginning phases of and getting ready to prepare a New Drug Application (NDA) to the FDA for a combination product. At this point we are preparing the Investigational New Drug (IND) application to be submitted to the FDA to initiate the clinical trials and will be preparing a pre-submission meeting request to the FDA before moving forward. Therefore, we are looking for an additional regulatory affairs expert freelancer with expertise in FDA drug application submissions (ICH, eCTD, IND, NDA, ANDA, 505(b)2, CDER, etc…) and meetings with the agency.
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