Preparation of regulatory documents including:

  • Clinical Overviews
  • Summaries of efficacy, safety and clinical pharmacology for CTDs
  • Investigator’s Brochures
  • Risk Management Plans
  • Briefing and Background documents prior to IND/CTA, end of Phase II, pre-MAA/NDA

Devising the Regulatory Strategy

Presentations and Discussions with Regulatory Authorities

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