Sovereign offers clinical/regulatory submission expertise. Our Clinical/Regulatory Affairs professionals work closely with our Research & Development, Quality Control and Quality Assurance personnel. Our cross-functional approach ensures that documents and data are presented in compliant format based on applicable electronic submission guidance's, regulations and specifications.

Sovereign's Clinical/Regulatory Affairs team has extensive experience in providing liaison support for agency interactions and can act as U.S. Agent for organizations seeking regulatory approval in the United States. The team also offers expert guidance and review capabilities throughout the electronic submission process.

  • Preparation and Submission of Electronic Common Technical Documents (eCTD)
  • Preparation of Structured Product Labeling (SPL) and Electronic Product Registration Submissions
  • DEA Registration and Compliance
  • Project Management and Strategic Guidance / Consulting
  • Compliance with cGMP, cGCP, and FDA regulations
  • Act as US Authorized Agent

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