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From complex regulatory affairs to dynamic CMC submission, SommaTech regulatory experts rapidly identify development, manufacturing or stability issues that could impact product registration.

Regulatory, Quality Assurance and CMC Support

  • Due Diligence for Products, Compounds, Process, and Supply Chain
  • CRO/CMO Selection
  • Quality Risk Analysis for Products and Processes
  • Novel Product Engineering Merged with Regulatory Strategy
  • Expert Advice From Submission through Pre-Approval Inspection