Regulatory & Medical 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

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