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Consulting

  • Strategic and regulatory advice for national / international Issues

  •  Strategy formation for new development concepts, partly
        in cooperation with RCPE

  • Choice of appropriate application procedures

  • Evaluation of regulatory or CMC documentation

  • Compilation of a complete MA dossier

  • Regulatory and commercial compliance   
        - Life Cycle Management (Variations, Renewal procedures,...)
        - Product Quality Reviews

  • Quality management

  • Preparation and attendance at meetings with authorities
      (pre-submission meetings, scientific advice)

  • Support in the area of CE-Certification

  • Health claims

  • Pharmacovigilance assistance

  • Non-Clinical & Clinical Studies

  • Application for SME status

  • Application for Scientific Advice related to Quality, Non-Clinic or Clinic