Medical Affairs

CSO Pharma actively supports you to fulfil the regulatory requirements as Marketing Authorisation Holder and pharmaceutical company from the development of drug-related information and update to the compliant distribution.

Accurate, timely and appropriate product information is crucial to ensure customer satisfaction, safety of your products and your reputation.

Medical Affairs / Medical Information Services

Answering of medical enquiries

  • Answering of medical enquiries
  • Service-Portal with online accessibility
  • 24/7 hotline including Interactive Voice Respond ("please press 1 for ...") and escalation process
  • Socialvigilance

Medical Affairs

  • Preparation of information material, training material and presentation
  • Medical Writing
  • Set-up and implementation of launch activities
  • Research and online surveys
  • Announcements in Product Information reference lists (i.e. Red- and Yellow List)
  • Product training for health care professionals, medical and scientific personnel and patients
  • Conduction of compliance training for field staff and service encounters
  • Data entry in the EU medicinal product dictionary (EVMPD)

Information Officer

  • If requested we take over the responsibility as QP for scientific advice / Information Officer as legally required.

Labeling Compliance

  • Preparation and/or review of PILs and SPCs (patient information leaflets and Summary of Product Characteristics)
  • PILs for visually handicapped and blind people
  • Creation and/or review of obligatory information texts according to regulatory requirements

Quality Management

  • Quality Management for pack material and product information
  • Preparation and maintenance of corresponding operating procedures

Do you have any questions? Please feel free to contact us for further information. We are looking forward to your enquiry.


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Medical Hotline

Medical enquiries answered competent & friendly at all hours including current statistics and important strategic reports >>