Regulatory

Consultancy to receive and maintain marketing  authorisations  &
clinical study documentation

Management of your regulatory projects
 
•  Advice on registration strategy (data review and assessment of feasibility)
•  Preparation and submission of Marketing Authorisation Applications,
   Drug Master Files and all types of registration documentation
   (NDA, ANDA, CTA, CTD, variation)
•  Negotiation with the authorities through the approval process
    (Preparation of responses and meetings)
•  Variation and maintenance of marketing authorisations and Drug Master Files
•  Advice on strategy of know-how protection for drug substances

Regulatorische Angelegenheiten Swissmedic

•  Betreuung Ihrer Swissmedic – Zulassungen
•  Verhandlungen & Korrespondenz mit den Behörden
•  Verlängerung der Zulassungen, Neuzulassungen, Änderungen