Achievements

Pharma

• Strategic development advice: pre-clinical, clinical, medico-marketing.
  This includes initial target indication(s), life-cycle management, market segmentation, drug re-profiling


• In depth evaluation of pre-clinical, Phase I, II and III data


• Interim Management positions


• Regulatory - Assistance with the preparation of NDAs / MAAs including:



• Statistical analysis plan
• Strategy for presentation of efficacy and safety data
• Pooled / meta-analyses
• Specific issues to be addressed


• Regulatory - Responses to regulatory questions including representing companies at meetings with Regulatory Authorities at all stages of development


• Written technical sections of Health Technology Appraisals for the UK National Institute for Health and Clinical Excellence (NICE)


• Business development - searching and evaluating potential in-licensing candidates; assisting with out-licensing and co-developments


• Pharmacovigilance: serious adverse event review and reporting, annual safety update reports


• Advisory Boards - participant as Clinical Expert as well as chairing and / or facilitating these meetings

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