Regulatory & Medical Affairs

Regulatory Affairs

  • EU marketing authorizations
  • e-CTD-dossiers according to current EU requirements and region specific dossiers for lead markets in LATAM, CIS and META
  • Support to customers submission of HELM Dossiers
  • Support of our licensing partners to maintain their registrations and keep the delivered products compliant to the registration dossier
  • Regulatory expert input during the deveolpment of drug products reagrding the current requirements of competent authorities
  • Global registration strategies

Medical Affairs

  • Plannning, coordination and quality management of bioequivalnce studies, clinical studies and toxicological assesssments
  • Clinical and non clinical overviews
  • Expert statements of efficacy and safety
  • Pharmacovigilance system in accordance with the current legal reuquirements