Medical Affairs / Medical Information

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. We offer:

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.

CSO MedInfo at Google+

Medical enquiries

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

Product information

As given for marketing authorisations medicinal product information texts (i.e. SPC) are also subject to strict regulatory requirements >>

Contact

Do you have a question - please feel free to contact us.
T +49 (0) 89 2033 53 59
F +49 (0) 89 809 193 80
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