Scientific competencies,
quick access
to information
Medical Affairs

Medical Affairs services provide greater support and flexibility for the Medical Management, thereby contributing towards constant scientific updating of Clients’ portfolio.  

Scientific know-how, access to updated information and rapid response times are specific characteristics of KEYPHARMA services in this area, which include:  

  • Scientific advice for the formulation of research protocols
  • Preparation and review of scientific documents in response to Regulatory Authorities’ deficiency letters
  • Contacts with key opinion leaders as well as Regulatory Authorities’ experts
  • Clinical Trial Applications to local and national Regulatory Authorities.
  • Medical Writing: clinical protocols, IMPDs, Non Clinical/Clinical Summaries and Overviews (Modules 2.4, 2.5, 2.6, 2.7) , ICH Clinical Protocols, Scientific Papers
  • Identification, Qualification and Audits of pre-clinical and clinical experimental sites
  • Pharmacovigilance: monitoring of the PV network, Adverse Drug Reports, Periodic Safety Update Reports, PV SOPs, QPPV services, Risk Management Plans, management of Eudravigilance in accordance with requirements established by the EU Commission.
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