Pharmapace, Inc.
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Contact Us
Pharmapace, Inc.
Home
About Us
  • Who Are We?
  • Leadership
  • Core Business
  • Therapeutic Experience
  • How We Manage Your Data
  • Drugs We Helped Approved
  • Events & Impact
  • Publications
Services
  • Biostatistics
  • Data Management
  • Statistical Programming
  • CDISC (SDTM/ADaM)
  • Regulatory Submissions
  • Clinical Data Integration
  • ClinicalTrials.gov Submit
  • Medical Writing
  • FSP
  • BIMO
  • PK/PD Analysis
  • Project Management
Contact Us
More
  • Home
  • About Us
    • Who Are We?
    • Leadership
    • Core Business
    • Therapeutic Experience
    • How We Manage Your Data
    • Drugs We Helped Approved
    • Events & Impact
    • Publications
  • Services
    • Biostatistics
    • Data Management
    • Statistical Programming
    • CDISC (SDTM/ADaM)
    • Regulatory Submissions
    • Clinical Data Integration
    • ClinicalTrials.gov Submit
    • Medical Writing
    • FSP
    • BIMO
    • PK/PD Analysis
    • Project Management
  • Contact Us
  • Home
  • About Us
    • Who Are We?
    • Leadership
    • Core Business
    • Therapeutic Experience
    • How We Manage Your Data
    • Drugs We Helped Approved
    • Events & Impact
    • Publications
  • Services
    • Biostatistics
    • Data Management
    • Statistical Programming
    • CDISC (SDTM/ADaM)
    • Regulatory Submissions
    • Clinical Data Integration
    • ClinicalTrials.gov Submit
    • Medical Writing
    • FSP
    • BIMO
    • PK/PD Analysis
    • Project Management
  • Contact Us

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
     

Pharmapce, Inc. 

10509 Vista Sorrento Pkwy, Ste 303, San Diego, CA 92121

🇺🇸 

Proud U.S.-Based Company. 

Proud U.S.-Based Team. 

Proud U.S.-Based Servers.  

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