Skip to main contentRegulatory 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