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Onyx Scientific

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Allied Services | Regulatory and Registration Support Services

We have extensive experience in the production of registration batches and
submission of dossiers for over 120 countries. We provide the following
product registration support services.

  • Manufacturing, packaging and release testing of registration batches
  • Stability study design and monitoring using ICH guidelines
  • Documentation provided in submission ready format
  • CMC section of NDA/PL
  • Customized technical reports
  • Validation master plan, protocols and report
  • Regulatory guidance from development to commercialization