• Preparation of Clinical Overviews (Expert Reports) for new molecular entities and Prescription only to OTC switches
    • Preparation of summaries of efficacy, safety and  clinical pharmacology for Common Technical Documents
    • Devising the Regulatory Strategy
    • Briefing and Background documents prior to IND/CTA, end of Phase II, pre-MAA/NDA
    • Presentations and Discussion with Regulatory Authorities
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