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Consultancy

Information sharing and solution suggestions on pharmaceuticals and health issues

Developing projects based on the needs via brainstorming meetings with the associated experts/key opinion leaders/authorities.

General project development

  • Drug development and research in humans
  • Ethical aspects of drug research and associated legal legislations
  • Promotional activities to enhance corporate image

Regulatory issues

  • Drug research in humans
  • Good promotional practice on pharmaceutical products

Product licensing issues

  • Preparation of clinical summaries of Common Technical Document
  • Package insert preparation
  • Summary of Product Characteristics (SPC) preparation and update

Other

  • Ethics Committee submission and other issues associated with drug research

Audit

  • Master study file audit
  • Study site audit
  • Contract research organization audit

Reporting on items related to areas of consulting

Consulting and reporting on other issues in fields of pharmaceuticals and health issues upon request