Regulatory Submissions (FDA NDA/EMA MAA)

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Expert support for FDA NDA and EMA MAA from planning to approval to help you navigate complex regulatory processes with proven success.

Our Services Include:

• Preparation of submission-ready SDTM and ADaM datasets
• Development of statistical analysis reports, TLFs, and reviewer guides
• Regulatory documentation support including ISS/ISE
• Compliance with FDA eCTD and EMA formatting standards
• Audit-readiness and BIMO inspection support