Regulatory Submissions (FDA NDA/EMA MAA)
Pharmapace offers expert support for global regulatory submissions, including FDA New Drug Applications (NDA) and EMA Marketing Authorization Applications (MAA). With a proven track record of successful approvals, we guide clients through every step of the submission process—from strategic planning and data preparation to final delivery of submission-ready materials. Our team ensures full compliance with CDISC standards and regulatory guidelines, producing high-quality deliverables that meet the rigorous expectations of global health authorities.
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