Dossier preparation

• Drug Master File (DMF) preparation, review, and submission to US Food and Drug Administration (FDA), Health Canada, as well as EMEA and European countries
• Technical review and revision of CTD sections, expert recommendation on content and format of DMF and finished drug product submissions
• Review of process validation protocols and reports, sterilization validation protocols and reports, aseptic process simulation (media fill)
  

• Assistance in replying to correspondence from regulatory authorities, including:

        -    Responses to deficiency letters, DMF Incomplete Letters, and administrative requests from FDA
        -    Clarifax, Notice of Deficiency and Notice of Non-Compliance (NODs, NONs) from Health Canada
        -    Resolution of complex submission issues with FDA reviewers
        -    Other assistance in regulatory communication and interpretation of correspondence from North American and European regions

• Expertise in electronic Common Technical Document (eCTD) format; preparation of new dossiers and conversion of existing paper submissions into eCTD format
• Regulatory Agent services for US and Canadian health authorities (FDA and Health Canada)

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